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Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).
Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Cancer Agents | Drug | Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients having a benefit after this specific cardio-oncology check up and follow up | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments | 5 years | |
| All relevants staisticals associations between adverse events and anticancer drugs | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering (or having suffered) from a cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joe-Elie Salem, MD, PhD | Contact | (0)1 42 17 85 33 | +33 | joe-elie.salem@aphp.fr |
| Stéphane Edehry, MD | Contact | (0)1 49 28 24 59 | +33 | stephane.edehry@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Saint-Antoine Hospital, Department of cardiology | Recruiting | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31189043 | Background | Salem JE, Allenbach Y, Vozy A, Brechot N, Johnson DB, Moslehi JJ, Kerneis M. Abatacept for Severe Immune Checkpoint Inhibitor-Associated Myocarditis. N Engl J Med. 2019 Jun 13;380(24):2377-2379. doi: 10.1056/NEJMc1901677. No abstract available. | |
| 31988143 | Derived | Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1):e000261. doi: 10.1136/jitc-2019-000261. |
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| All relevant statistical associations between cardiovascular toxicities, and anticancer drugs | 5 years |
| All relevants statistical associations between cardiovascular side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments | 5 years |
| All relevant statistical associations between duration and type of treatement used to manage cardiovascular side effects induced by oncology treatments, and overall survival | 5 years |
| All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments | 5 years |
| All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival | 5 years |
| All relevant statistical associations between the pre therapeutic cardiovascular checkup and follow up for patients with cancer or history of cancer, and the occurence of cardiovascular toxicities of oncology treatments. | 5 years |
| All relevant statistical associations between metabolic toxicities, and anticancer drugs | 5 years |
| All relevants statistical associations between metabolic side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments | 5 years |
| All relevant statistical associations between duration and type of treatement used to manage metabolic side effects induced by oncology treatments, and overall survival | 5 years |
| All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments | 5 years |
| All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival | 5 years |
| All relevant statistical associations between the pre therapeutic metabolic checkup and follow up for patients with cancer or history of cancer, and the occurence of metabolic toxicities of oncology treatments. | 5 years |
| AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM | Recruiting | Paris | 75013 | France |
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| AP-HP, Tenon Hospital, Department of Cardiology | Recruiting | Paris | 75020 | France |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D008659 | Metabolic Diseases |
| D014652 | Vascular Diseases |
| D006331 | Heart Diseases |
| D066126 | Cardiotoxicity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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