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Impact of screening nodes mediastinal by PET, at different times of the management of cancer disease, remain unclear.
Benefits of combined PET and puncture with echoendoscopy for the diagnosis subsequent therapeutic management should be evaluated in these different contexts.
We would like to demonstrate the clinical utility of this association to replace more invasive diagnostic procedures and to assess the impact of the puncture on a possible modification of the therapeutic management.
It is a single center prospective diagnostic assessment
Main objective :
Assess the performance (in terms of sensitivity) of guided punction by echoendoscopy in the characterization of hypermetabolic mediastinal lymph nodes in PET, in a context of New cancer or cancer recurrence.
Conduct of the study :
When a patient has had a PET scan showing a hypermetabolic or mediastinal lymph nodes in the lower, middle or posterior, his case is presented in a multidisciplinary meeting (PCR # 1), with definition of diagnostic strategy:
Approved indication is achieve a biopsy surgically to have a histological documentation of mediastinal lymph nodes with obvious impact on treatment decisions.
We distinguish two groups of patients based on the feasibility of the surgical procedure:
Group A biopsy is surgically feasible
Group B: biopsy by surgery can not be performed (against medical contraindications or anesthetics) at that moment, definition of therapeutic strategy that was decided in the absence of histological documentation:
EUS is performed by oesophageal for two patient groups for the two groups of patients (within a maximum period of six weeks after the PET scan), under general anesthesia and endoscopic control.
According the pathological findings, the therapeutic strategy is defined in a second PCR (PCR # 2), to assess the impact of the puncture:
A patient monitoring will be conducted for 12 months. The clinical and radiological data carried over the standard of care of the patient will be collected. Achieving a thoracoabdominopelvic scanner (TAP) at 1 year to characterize the evolution of the disease marks the end of the study for the patient.
For the patients who have had a negative biopsy, monitoring will involve a scanner TAP 6 month and 12 month then consultation with the oncologist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypermetabolic mediastinal lymph nodes in PET, | Other | hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided punction of mediastinal lymphadenopathy by echoendoscopy | Procedure | EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion. Pathological samples are taken : 3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture | The performance of EUS-guided biopsy has been evaluated in terms of sensitivity. EUS-guided was performed after detection of lymph nodes with positron emission tomography (PET). In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury. PET, the reference technique (gold standard), is followed for 12 months. Sensitivity is the rate of subjects with a diagnosis of malignancy (excluding the results atypical / suspicious or non-contributory) according the results of EUS among all subjects with a neoplastic disease by the gold reference. To sum up , the sensitivity corresponds to the rate of patients detected as "malignant" with the new technique (EUS-guided), among the patients detected as "malignant" at the reference PET examination (12 months assessment). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Predictive Value | The negative predictive value of EUS-guided biopsy has been evaluated by the rate of subjects with a diagnosis of benign pathology according the gold standard (PET) among all subjects for wich EUS reveal a benign pathology (excluding atypical/suspects findings or non contributory) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects - Number of Adverse Event Declared According to DINDO Classification | In all cases the side effects associated with the implementation of the guided puncture EUS has been collected and classified according to the classification of surgical complications of Clavien-Dindo [P Clavien and al. Ann Surg 2009, 250: 187-96]. Classification of surgical complications of Clavien-Dindo ranges from grade 1 (any deviation from the normal postoperative course) to grade 5 (death of patient) |
Inclusion Criteria:
Any patients who have had PET showing one or more hypermetabolic lymphadenopathy in middle mediastinum and/or lower and/or posterior, and requiring diagnostic certainty for support.
PET scans performed in these particulars :
PET, the result is positive :
Patient with indication of diagnostic procedure surgically (whether realized or not)
Lymph node(s) available(s) puncture by EUS esophageal, so for a technically feasible for esophageal puncture (without vascular recusants structures)
Age ≥ 18 years.
PET scan performed within 6 weeks before EUS
Platelets ≥ 70 000/mm3; TP ≥ 60%.
Patient of childbearing age with negative pregnancy test and / or a contraception.
Patient gave informed consent signed.
Patient affiliated to a social security scheme.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insitut Bergonie | Bordeaux | Grionde | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35341993 | Background | Bechade D, Bellera C, Gauquelin L, Soubeyran I, McKelvie-Sebileau P, Debled M, Chomy F, Roubaud G, Fonck M, Pernot S, Roch A, Cazeau AL. Diagnostic accuracy and clinical impact of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in Positron Emission Tomography - Computed Tomography (PET-CT)-positive mediastinal lymphadenopathies in patients with thoracic or extra-thoracic malignancies. Clin Res Hepatol Gastroenterol. 2022 May;46(5):101912. doi: 10.1016/j.clinre.2022.101912. Epub 2022 Mar 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypermetabolic Mediastinal Lymph Nodes in PET, | Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence. Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion. Pathological samples are taken : 3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken. PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hypermetabolic Mediastinal Lymph Nodes in PET, | Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence. Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion. Pathological samples are taken : 3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken. PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture | The performance of EUS-guided biopsy has been evaluated in terms of sensitivity. EUS-guided was performed after detection of lymph nodes with positron emission tomography (PET). In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury. PET, the reference technique (gold standard), is followed for 12 months. Sensitivity is the rate of subjects with a diagnosis of malignancy (excluding the results atypical / suspicious or non-contributory) according the results of EUS among all subjects with a neoplastic disease by the gold reference. To sum up , the sensitivity corresponds to the rate of patients detected as "malignant" with the new technique (EUS-guided), among the patients detected as "malignant" at the reference PET examination (12 months assessment). | Patient eligible and evaluable for primary endpoint (N=47) (excluded patients with non-contributory histological results, puncture not carried out, radiological monitoring not carried out) | Posted | Number | 95% Confidence Interval | percentage | 12 months |
|
Collection of adverse events (AEs) for 45 days after echo-guided puncture or without time limit if the AE is considered to be related to the puncture, an average of 1 year.
Adverse Event Terms has not been reported in the CRF. AEs related to possible complementary treatments such as chemotherapy has not to been reported in the CRF.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypermetabolic Mediastinal Lymph Nodes in PET, | Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence. Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion. Pathological samples are taken : 3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken. PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Non-systematic Assessment | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left inguinal hernia aggravation | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dominique Bechade, Coordinating Investigator | Institute Bergonie | 0556337805 | d.bechade@bordeaux.unicancer.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2016 | Apr 26, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PET scan | Device | The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts |
|
| Matching Between Therapeutic Strategies RCP1/RCP2 |
Impact of the management of patient : Concordance between therapeutic strategies before the results of the endoscopy (Multidisciplinary consultation meeting 1 (RCP1) in absence of documentation) and after the results of endoscopy (Multidisciplinary consultation meeting 2 (RCP2) post-documentation) for the eligible and evaluable population |
| 12 months |
| Clinical Utility (Avoid More Invasive Procedure) | The clinical utility of puncture under echo-endoscopy puncture has been considered to have a clinical utility, if it allows the patient to avoid more invasive diagnostic procedures (mediastinoscopy or thoracoscopy) or if it allows the patient to benefit from appropriate treatment (result of the malignant biopsy) or to avoid receiving unjustified treatment (result of the benign biopsy): case of patients well classified as malignant/benign by puncture under echo-endoscopy. The puncture will be considered to have no clinical utility if the result of the puncture under echo-endoscopy is invalidated by the reference examination, or if the result of the puncture does not allow a diagnosis to be made. | 12 months |
| 12 months |
| Non-contributory histological result |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Therapeutic strategy (absence of documentation) | Therapeutic strategy before the results of the endoscopy | Count of Participants | Participants |
|
| Therapeutic strategy after documentation | Therapeutic strategy after documentation (results of the endoscopy) for patients with available data | missing data | Count of Participants | Participants |
|
| T status (Classification of Malignant Tumors) | The letter "T" corresponds to the initial tumour. T classification is rated from TX (when primary lesion is not determined not assessable) or T0 (when the primary lesion is not localised) to T4 for the most extensive tumours. | missing data | Count of Participants | Participants |
|
| N status (Classification of Malignant Tumors) | N means lymph nodes. It describes the spread of cancer to the lymph nodes surrounding the organ. N0 means that the cancer has not spread to any nearby lymph nodes. N1, N2 or N3 means that the cancer has spread to the lymph nodes. N+ means presence of lymph node. NX means non-assessable adenopathies. | Patients with available TNM status | Count of Participants | Participants |
|
| M status (Classification of Malignant Tumors) | M classification is rated M0 in the absence of known metastases, M1 in their presence, MX when metastases are not assessable. | Patients with available TNM status | Count of Participants | Participants |
|
| Total number of lymph nodes per patient | Median | Full Range | lymph nodes |
|
| Description |
|---|
| OG000 | Hypermetabolic Mediastinal Lymph Nodes in PET, | Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence. Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion. Pathological samples are taken : 3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken. PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts |
|
|
| Secondary | Negative Predictive Value | The negative predictive value of EUS-guided biopsy has been evaluated by the rate of subjects with a diagnosis of benign pathology according the gold standard (PET) among all subjects for wich EUS reveal a benign pathology (excluding atypical/suspects findings or non contributory) | Posted | Number | 95% Confidence Interval | percentage | 12 months |
|
|
|
| Secondary | Matching Between Therapeutic Strategies RCP1/RCP2 | Impact of the management of patient : Concordance between therapeutic strategies before the results of the endoscopy (Multidisciplinary consultation meeting 1 (RCP1) in absence of documentation) and after the results of endoscopy (Multidisciplinary consultation meeting 2 (RCP2) post-documentation) for the eligible and evaluable population | Patients eligible and evaluable with available pre (before endoscopy results) AND post documentation (after endoscopy results) therapeutic strategies. Of note, 6 patients without therapeutic strategies after endoscopy results. | Posted | Number | 95% Confidence Interval | percentage of patients | 12 months |
|
|
|
| Secondary | Clinical Utility (Avoid More Invasive Procedure) | The clinical utility of puncture under echo-endoscopy puncture has been considered to have a clinical utility, if it allows the patient to avoid more invasive diagnostic procedures (mediastinoscopy or thoracoscopy) or if it allows the patient to benefit from appropriate treatment (result of the malignant biopsy) or to avoid receiving unjustified treatment (result of the benign biopsy): case of patients well classified as malignant/benign by puncture under echo-endoscopy. The puncture will be considered to have no clinical utility if the result of the puncture under echo-endoscopy is invalidated by the reference examination, or if the result of the puncture does not allow a diagnosis to be made. | Patients evaluable for clinical utility | Posted | Number | 95% Confidence Interval | percentage of patients | 12 months |
|
|
|
| Other Pre-specified | Side Effects - Number of Adverse Event Declared According to DINDO Classification | In all cases the side effects associated with the implementation of the guided puncture EUS has been collected and classified according to the classification of surgical complications of Clavien-Dindo [P Clavien and al. Ann Surg 2009, 250: 187-96]. Classification of surgical complications of Clavien-Dindo ranges from grade 1 (any deviation from the normal postoperative course) to grade 5 (death of patient) | Patients with at least one adverse event with Dindo classification (N=38) | Posted | Number | Number of adverse event per grade | 12 months | Number of adverse event | Number of adverse event |
|
|
|
| 0 |
| 47 |
| 34 |
| 47 |
| 34 |
| 47 |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE v5.0 | Non-systematic Assessment | Blood and lymphatic system disorders |
|
| Heart failure | Cardiac disorders | CTCAE v5.0 | Non-systematic Assessment | Cardiac disorders |
|
| Ascites | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Esophageal stenosis | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment | Gastrointestinal disorders |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE v5.0 | Non-systematic Assessment | General disorders and administration site conditions |
|
| Kidney infection | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment | Infections and infestations |
|
| Urinary tract infection | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment | Infections and infestations |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE v5.0 | Non-systematic Assessment | Injury, poisoning and procedural complications |
|
| Platelet count decreased | Investigations | CTCAE v5.0 | Non-systematic Assessment | Investigations |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v5.0 | Non-systematic Assessment | Metabolism and nutrition disorders |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v5.0 | Non-systematic Assessment | Metabolism and nutrition disorders |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment | Musculoskeletal and connective tissue disorders |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Non-systematic Assessment | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment | Renal and urinary disorders |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment | Renal and urinary disorders |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment | Respiratory, thoracic and mediastinal disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Alteration of the general condition | General disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Ferriprive anemia on melena | Blood and lymphatic system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Multifactorial anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Febrile aplasia | Blood and lymphatic system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Headaches | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Cervicalgies | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Surgery for liver metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Non-systematic Assessment |
|
| Hypoglycemic coma | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Right cruralgia | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Cryotherapy for pleuropulmonary metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Non-systematic Assessment |
|
| Removal of the left cervical lymph node | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Non-systematic Assessment |
|
| Oedemato-ascitic decompensation | Hepatobiliary disorders | CTCAE v5.0 | Non-systematic Assessment | OEDEMATO-ASCITIC DECOMPENSATION |
|
| Diarrhoea | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Dysesthesia | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Right foot dysesthesia | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Dysphony | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Acute dyspney | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Dysury | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Pulmonary embolisme | Vascular disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Bilateral pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Febrile episode | General disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Extra systole | Cardiac disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Fracture of the left pubic ramus | Injury, poisoning and procedural complications | CTCAE v5.0 | Non-systematic Assessment |
|
| Hematury | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Hemoptysia | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Hemorragia | Vascular disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Hepatite C | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment |
|
| Hyperkalemy | Metabolism and nutrition disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Kidney failure | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Laryngospasmus | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Cerebrale mestastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Non-systematic Assessment |
|
| Mucite | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Mycosis | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment |
|
| Lingual mycosis | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Oedeme | General disorders | CTCAE v5.0 | Non-systematic Assessment | Left lower limb |
|
| Oesophagite | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Chest tightness | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Peritoneal kystic mesotheliome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Symptomatoc intramedullary progression | General disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Tumoral progression | General disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Pyelonephrite with E.COLI and enterobactery | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment |
|
| Gastroesophageal reflux | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Lung metastasis resection + lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Non-systematic Assessment |
|
| Rhinite | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Sepsis of probable urinary origin | Infections and infestations | CTCAE v5.0 | Non-systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Cave syndrome and jugular thrombosis | Cardiac disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Vertebral compression | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment | T11 AND L5 |
|
| Vertebral compression | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Non-systematic Assessment | T11, T12 AND L1 |
|
| Thrombopenia | Investigations | CTCAE v5.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Xeroderma | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Esophageal stenosis | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
| Aggravation left inguinal hernia | Gastrointestinal disorders | CTCAE v5.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| Title | Measurements |
|---|
|
| IIIb |
|