Clinical trial NCT03882580: Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care
Official title: Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Complication
Cardiovascular Insufficiency
Cardiac Complication
Oncologic Complications
Cardiac Insufficiency
Metabolic Disorder
Vascular Disorder
Cardiac Disorder
Keywords: anticancer drugs
cardiac toxicities
cardiovascular prevention
vascular toxicities
metabolic toxicities
adverse drug reactions
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering (or having suffered) from a cancer

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Suffering a cancer
* Evaluated within a cardio-oncology program

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients having a benefit after this specific cardio-oncology check up and follow up
timeFrame: 5 years
Secondary outcomes:
measure: Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments
timeFrame: 5 years
measure: All relevants staisticals associations between adverse events and anticancer drugs
timeFrame: 5 years
measure: All relevant statistical associations between cardiovascular toxicities, and anticancer drugs
timeFrame: 5 years
measure: All relevants statistical associations between cardiovascular side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments
timeFrame: 5 years
measure: All relevant statistical associations between duration and type of treatement used to manage cardiovascular side effects induced by oncology treatments, and overall survival
timeFrame: 5 years
measure: All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments
timeFrame: 5 years
measure: All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: All relevant statistical associations between metabolic toxicities, and anticancer drugs
timeFrame: 5 years
measure: All relevants statistical associations between metabolic side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments
timeFrame: 5 years
measure: All relevant statistical associations between duration and type of treatement used to manage metabolic side effects induced by oncology treatments, and overall survival
timeFrame: 5 years
measure: All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments
timeFrame: 5 years
measure: All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Saint-Antoine Hospital, Department of cardiology
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
city: Paris
country: France
facility: AP-HP, Tenon Hospital, Department of Cardiology
Study officials:
References:
citation: 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.
citation: 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.