NCT03882580

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

March 13, 2019

Last Update Submit

April 20, 2023

Conditions

Cardiovascular ComplicationCardiovascular InsufficiencyCardiac ComplicationOncologic ComplicationsCardiac InsufficiencyMetabolic DisorderVascular DisorderCardiac Disorder

Keywords

anticancer drugscardiac toxicitiescardiovascular preventionvascular toxicitiesmetabolic toxicitiesadverse drug reactions

Outcome Measures

Primary Outcomes (1)

  • Number of patients having a benefit after this specific cardio-oncology check up and follow up

    5 years

Secondary Outcomes (14)

  • 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

  • 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

  • +9 more secondary outcomes

Interventions

Anti-Cancer AgentsDRUG

Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering (or having suffered) from a cancer

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AP-HP, Saint-Antoine Hospital, Department of cardiology

Paris, 75012, France

RECRUITING

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, 75013, France

RECRUITING

AP-HP, Tenon Hospital, Department of Cardiology

Paris, 75020, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31189043BACKGROUND

  • 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.

    PMID: 31988143DERIVED

MeSH Terms

Conditions

Heart FailureMetabolic DiseasesVascular DiseasesHeart DiseasesCardiotoxicityDrug-Related Side Effects and Adverse Reactions

Interventions

Antineoplastic Agents

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Joe-Elie Salem, MD, PhD

CONTACT

(0)1 42 17 85 33joe-elie.salem@aphp.fr

Stéphane Edehry, MD

CONTACT

(0)1 49 28 24 59stephane.edehry@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant director, clinical investigation center Paris Est

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 20, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations

FR(3)