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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01130-39 | Registry Identifier | IDRCB - French Agency for the Safety of Health Products |
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| Name | Class |
|---|---|
| Malakoff-Humanis | UNKNOWN |
| Fondation Apicil | OTHER |
| Fédération Leucémie Espoir | UNKNOWN |
| Biogaran |
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INTRODUCTION: Approximately 44% of cancer survivors experience a deteriorated quality of life 5 years after diagnosis due to late onset of complications related to cancer treatments. The objective of the study is to evaluate the incidence rates of treatment-related complications, identify sub-clinical abnormalities and risk factors in patients participating in the PASCA post-treatment program.
METHOD: PASCA is a single-center, interventional cohort study of adult patients who received at least chemotherapy and with a complete remission to a testicular germ cell tumor, primary non-metastatic invasive breast carcinoma, high-grade soft tissue sarcoma, osteosarcoma, Ewing's sarcoma, acute myeloid leukemia, Hodgkin's or aggressive non-Hodgkin's lymphoma. Four assessment visits will be scheduled at 1 month (T1), 6 months (T2), 24 months (T3) and 60 months (T4) after completion of treatment. During these visits, 19 complications will be screened and follow-up care will be systematically offered to the health professional concerned by the complication in case of a positive result. The screening will contain the following elements: screening self-questionnaires, quality of life questionnaire, 12 biological parameters, a urinalysis evaluating hematuria, proteinuria, and leukocyturia, a spirometry, an electrocardiogram, 5 tests evaluating physical condition, vital signs and the perimetric measurement between both arms.
DISCUSSION: This systematic screening could highlight a number of complications occurring after cancer treatments. Sub-clinical abnormalities and new risk factors could also be identified. This new organization of care could improve the quality of life of adult cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PASCA intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PASCA intervention | Other | At each study visit (T1 = 1 month, T2 = 6 months, T3 = 24 months, T4 = 60 months), an exhaustive screening of complications as well as associated sub-clinical abnormalities and risk factors previously identified as such in the literature, will be conducted. Management of complications consists of referring the patient to a healthcare professional belonging to the PASCA network based on the test results. Referral is defined by referring to pre-established decision trees. It is made to a specialist physician, a health professional from the paramedical field or the patient's general practitioner who confirms the diagnosis if necessary and initiates the patient's care and follow-up. These patients also receive their usual follow-up in the context of their tumor pathology in oncology and onco-hematology. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of social precariousness | Diagnosed by a social worker | Month 1 |
| Change from Baseline return to work issues incidence at 60 months | Diagnosed by a social worker | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline cognitive problems incidence at 60 months | Diagnosed by a neurologist | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline anxiety crises incidence at 60 months | Diagnosed by a psychologist or psychiatrist | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline depressive events incidence at 60 months | Questionnaire "HADS-D" (Hospital Anxiety and Depression scale) | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline physical deconditioning incidence at 60 months | A value below the lower limit on at least two of the following physical tests
| Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline overweight/obesity incidence at 60 months |
| Month 1, Month 6, Month 24, Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the PASCA program: referrals made through the network | Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals) | Month 6, Month 24, Month 60 |
| Evaluate the PASCA program: time between patient referral and completion of the first consultation |
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Patients will be excluded if they have a history or coexistence of another primary cancer (except basal cell skin cancer), are participating in another study affecting the primary outcome, are deprived of liberty, or reside outside the Auvergne-Rhône-Alpes region or the Saône-et-Loire department.
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| Name | Affiliation | Role |
|---|---|---|
| Mauricette MICHALLET, PhD, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Leon Berard | Lyon | 69373 | France |
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| UNKNOWN |
| Le défi Anthony | UNKNOWN |
| Novartis | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
All patients in the study will benefit from the PASCA post-treatment program with 4 visits : at 1 month (T1), 6 month (T2), 24 month (T3) and 60 month (T4) after the end of treatment.
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|
| Change from Baseline chronic pain incidence at 60 months |
| Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline dermatological disorders incidence at 60 months | Common Terminology Criteria for Adverse Events (CTCAE) v5 | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline gastrointestinal disorders incidence at 60 months | Common Terminology Criteria for Adverse Events (CTCAE) v5 | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline sexual disorders incidence at 60 months | Questionnaire "Sexualité VICAN5" | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline hypogonadism incidence at 60 months | Presence of clinical signs as defined by the International Society for Sexual Medicine A value below the lower limit on at least one of the following blood assay:
| Month 1, Month 6, Month 24, Month 60 |
| Change from 24 months premature ovarian failure incidence at 60 months |
| Month 24, Month 60 |
| Change from Baseline osteoporosis incidence at 60 months | T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline chronic kidney failure incidence at 60 months | Diagnosed on the basis of 2 blood tests within 3 months using the same technique showing a decrease in GFR to < 60ml/min/1.73m2, estimated from creatinine levels using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009), albuminuria or proteinuria positive, hematuria, leukocyturia > 10/mm3, or morphological abnormality on renal ultrasound. | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline heart failure incidence at 60 months | Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline coronary heart disease incidence at 60 months | Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease | Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline respiratory failure incidence at 60 months |
| Month 1, Month 6, Month 24, Month 60 |
| Change from Baseline hypothyroidism incidence at 60 months |
| Month 1, Month 6, Month 24, Month 60 |
Average time (days) between patient referral and completion of the first consultation |
| Month 6, Month 24, Month 60 |
| Evaluate the PASCA program: patients description |
| Month 1, Month 6, Month 24, Month 60 |
| Evaluation of the patient adherence | Ratio of the number of prescriptions issued for referral consultations /number of referral consultations actually attended by the patient | Month 1, Month 6, Month 24, Month 60 |
| Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues. |
| Month 6, Month 24, Month 60 |
| Identification of risk factors associated with complications occurring during follow-up. | Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up. | Month 1, Month 6, Month 24, Month 60 |
| Description of the Global Longitudinal Strain | Evolution of the Global Longitudinal Strain in absolute value, relative to a later value | Month 6, Month 24, Month 60 |
| Description of the troponin I level | Evolution of the troponin I level relative to a later value | Month 6, Month 24, Month 60 |
| Description of the Glomerular Filtration Rate | Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value | Month 6, Month 24, Month 60 |
| Description of spirometry values | Evolution of spirometry values relative to later values :
| Month 6, Month 24, Month 60 |
| Incidence of diabetes mellitus | Level of fasting blood glucose | Month 6, Month 24, Month 60 |
| Incidence of untreated high blood pressure | Measure of systolic blood pressure | Month 6, Month 24, Month 60 |
| Incidence of hypertriglyceridemia | Level of triglyceridemia | Month 6, Month 24, Month 60 |
| Incidence of hyper-LDL-cholesterolemia | Level of LDL-cholesterolemia | Month 6, Month 24, Month 60 |
| Incidence of low level of physical activity | Questionnaire "Godin-Shephard Leisure-Time Physical Activity" | Month 6, Month 24, Month 60 |
| Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3) | Level of 25(OH) vitamin D (D2+D3) | Month 6, Month 24, Month 60 |
| Description of carcinogenic products consumption (tobacco, alcohol, cannabis) |
| Month 1, Month 6, Month 24, Month 60 |
| Evaluation of the Progression-free survival | Evaluation of the Progression-free survival | Month 6, Month 24, Month 60 |
| Evaluation of the Survival without an increase in the number of complications, among those studied | Evaluation of the Survival without an increase in the number of complications, among those studied | Month 6, Month 24, Month 60 |
| Evaluation of the event-free survival | Evaluation of the event-free survival | Month 6, Month 24, Month 60 |
| identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up | measurement of the association between demographics, clinical cancer and treatment-related parameters and the occurence of a type of complication during the follow-up | Month 1, Month 6, Month 24 and Month 60 |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| D012512 | Sarcoma, Ewing |
| D015470 | Leukemia, Myeloid, Acute |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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