Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

Recruiting

• Conditions: Cardiac Insufficiency; Vascular Disorder; Cardiovascular Complication; Metabolic Disorder; Cardiac Disorder; Cardiovascular Insufficiency; Cardiac Complication; Oncologic Complications

• Registration Number: NCT03882580
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients having a benefit after this specific cardio-oncology check up and follow up	5 years

Secondary Outcome Measures

Name	Time	Method
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 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 staisticals associations between adverse events and anticancer drugs	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 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
Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments	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 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 cardiovascular toxicities, and anticancer drugs	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 metabolic toxicities, and anticancer drugs	5 years

Trial Locations

Locations (3)

AP-HP, Saint-Antoine Hospital, Department of cardiology; 🇫🇷 Paris, France

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM; 🇫🇷 Paris, France

AP-HP, Tenon Hospital, Department of Cardiology; 🇫🇷 Paris, France