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

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ClinicalTrials.gov Identifier: NCT03882580
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, 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).

Condition or disease Intervention/treatment
Cardiovascular Complication Cardiovascular Insufficiency Cardiac Complication Oncologic Complications Cardiac Insufficiency Metabolic Disorder Vascular Disorder Cardiac Disorder Drug: Anti-Cancer Agents

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Intervention Details:
  • Drug: Anti-Cancer Agents
    Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects


Primary Outcome Measures :
  1. Number of patients having a benefit after this specific cardio-oncology check up and follow up [ Time Frame: 5 years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering (or having suffered) from a cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882580


Contacts
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Contact: Joe-Elie Salem, MD, PhD (0)1 42 17 85 33 ext +33 joe-elie.salem@aphp.fr
Contact: Stéphane Edehry, MD (0)1 49 28 24 59 ext +33 stephane.edehry@aphp.fr

Locations
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France
AP-HP, Saint-Antoine Hospital, Department of cardiology Recruiting
Paris, France, 75012
Contact: Edehry Stephane, MD    (0)1 49 28 24 59 ext +33    stephane.edehry@aphp.fr   
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM Recruiting
Paris, France, 75013
Contact: Joe-Elie Salem, Md, PhD    (0)1 42 17 85 33 ext +33    joe-elie.salem@aphp.fr   
AP-HP, Tenon Hospital, Department of Cardiology Recruiting
Paris, France, 75020
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03882580    
Other Study ID Numbers: CIC1421-19-05
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
anticancer drugs
cardiac toxicities
cardiovascular prevention
vascular toxicities
metabolic toxicities
adverse drug reactions
Additional relevant MeSH terms:
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Vascular Diseases
Heart Failure
Heart Diseases
Metabolic Diseases
Disease
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Cardiovascular Diseases
Antineoplastic Agents