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NCT Number: NCT03882580

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

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).

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Key information

Conditions

Cardiovascular Complication Cardiac Complication Cardiac Disorder Cardiac Insufficiency Cardiotoxicity Cardiovascular Diseases Cardiovascular Insufficiency Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Metabolic Diseases Metabolic Disorder Nutritional and Metabolic Diseases Oncologic Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Vascular Diseases Vascular Disorder Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Anti-Cancer Agents

Drug

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

Primary outcomes

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

    Time frame: 5 years

Secondary outcomes

  1. Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments

    Time frame: 5 years

  2. All relevants staisticals associations between adverse events and anticancer drugs

    Time frame: 5 years

  3. All relevant statistical associations between cardiovascular toxicities, and anticancer drugs

    Time frame: 5 years

  4. All relevants statistical associations between cardiovascular side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments

    Time frame: 5 years

  5. All relevant statistical associations between duration and type of treatement used to manage cardiovascular side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  6. All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments

    Time frame: 5 years

  7. All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  8. 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.

    Time frame: 5 years

  9. All relevant statistical associations between metabolic toxicities, and anticancer drugs

    Time frame: 5 years

  10. All relevants statistical associations between metabolic side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments

    Time frame: 5 years

  11. All relevant statistical associations between duration and type of treatement used to manage metabolic side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  12. All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments

    Time frame: 5 years

  13. All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival

    Time frame: 5 years

  14. 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.

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Joe-Elie Salem, MD, PhD

CONTACT

[email protected]

(0)1 42 17 85 33 ext. +33

Stéphane Edehry, MD

CONTACT

[email protected]

(0)1 49 28 24 59 ext. +33

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: NEOCARDIO

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Mar 20, 2019
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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