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| ID | Type | Description | Link |
|---|---|---|---|
| I 124407 | Other Identifier | Roswell Park Cancer Institute |
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RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires
Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.
After completion of study treatment, patients are followed for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). |
|
| Arm II | Experimental | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 stereotactic body radiation therapy | Radiation | Patients undergo 1 high-dose fraction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AE Grade 3 or Higher Toxicity | Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse. | 1year |
| Overall Survival | Median overall survival | 5 years |
| Correlation Between Blood and Serum Markers and Survival and Toxicity | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anurag K. Singh, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States | ||
| SUNY Upstate Medical University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 High-dose Fraction SBRT | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction |
| FG001 | 3 High-dose Fractions SBRT | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 High-dose Fraction SBRT | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction |
| BG001 | 3 High-dose Fractions SBRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of AE Grade 3 or Higher Toxicity | Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse. | All treated and eligible patients | Posted | Count of Participants | Participants | 1year |
|
Baseline, weekly until 30 day follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 High-dose Fraction SBRT | Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). stereotactic body radiation therapy: Patients undergo 1 high-dose fraction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 7168451300 | adrienne.groman@roswellpark.org |
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| 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 | Oct 10, 2017 | Apr 15, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Arm II stereotactic body radiation therapy |
| Radiation |
Patients undergo 3 high-dose fractions |
|
| Syracuse |
| New York |
| 13210 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Overall Survival | Median overall survival | All treated and eligible patients | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
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| Primary | Correlation Between Blood and Serum Markers and Survival and Toxicity | Data was not collected for this outcome | Posted | 4 years |
|
|
| 33 |
| 49 |
| 2 |
| 49 |
| 38 |
| 49 |
| EG001 | 3 High-dose Fractions SBRT | Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. stereotactic body radiation therapy: Patients undergo 3 high-dose fractions | 29 | 49 | 5 | 49 | 36 | 49 |
| Lung infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Chest discomfort | General disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Disease progression | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | Systematic Assessment |
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| Orchitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Radiation pneumonitis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Weight decreased | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Dementia | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Muscle contractions involuntary | Nervous system disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Confusional state | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Hallucination | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
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| Renal pain | Renal and urinary disorders | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Painful respiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Haematoma | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |