Cardiovascular ComplicationNEOCARDIONCT03882580
Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care
An observational study of Cardiovascular Complication and Cardiovascular Insufficiency, run by Groupe Hospitalier Pitie-Salpetriere at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Complication, Cardiovascular Insufficiency, Cardiac Complication
- What is being tested?
- Anti-Cancer Agents
- How many people
- 5,000 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2019to 1 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering (or having suffered) from a cancer
Who may be able to join
- Suffering a cancer
- Evaluated within a cardio-oncology program
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, France, 75013
Joe-Elie Salem, Md, PhD, (0)1 42 17 85 33 ext. +33, joe-elie.salem@aphp.fr
- Recruiting
AP-HP, Saint-Antoine Hospital, Department of cardiology
Paris, 75012
Edehry Stephane, MD, (0)1 49 28 24 59 ext. +33, stephane.edehry@aphp.fr
- Recruiting
AP-HP, Tenon Hospital, Department of Cardiology
Paris, 75020
About this study
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).
Read the 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.
- Conditions
- Cardiovascular Complication, Cardiovascular Insufficiency, Cardiac Complication, Oncologic Complications, Cardiac Insufficiency, Metabolic Disorder
- Being tested
- Anti-Cancer Agents
- Keywords
- anticancer drugs, cardiac toxicities, cardiovascular prevention, vascular toxicities, metabolic toxicities, adverse drug reactions
- Medical subject headings
- Heart Failure, Metabolic Diseases, Vascular Diseases, Heart Diseases, Cardiotoxicity, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Cancer AgentsDrug
Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients having a benefit after this specific cardio-oncology check up and follow up
Measured: 5 years
Secondary outcomes (14)
Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments
Measured: 5 years
All relevants staisticals associations between adverse events and anticancer drugs
Measured: 5 years
All relevant statistical associations between cardiovascular toxicities, and anticancer drugs
Measured: 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
Measured: 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
Measured: 5 years
All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments
Measured: 5 years
All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival
Measured: 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.
Measured: 5 years
All relevant statistical associations between metabolic toxicities, and anticancer drugs
Measured: 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
Measured: 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
Measured: 5 years
All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments
Measured: 5 years
All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882580
- Sponsor's protocol ID
- CIC1421-19-05
- Acronym
- NEOCARDIO
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31189043Dolladille 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.
PubMed 31988143
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03882580
- Acronym / sponsor ID
- NEOCARDIO / CIC1421-19-05
- Conditions
- Cardiovascular Complication, Cardiovascular Insufficiency, Cardiac Complication, Oncologic Complications, Cardiac Insufficiency, Metabolic Disorder
- Keywords
- anticancer drugs, cardiac toxicities, cardiovascular prevention, vascular toxicities, metabolic toxicities, adverse drug reactions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering (or having suffered) from a cancer
Key inclusion criteria (2 listed)
- Suffering a cancer
- Evaluated within a cardio-oncology program
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Cancer AgentsDrugs and treatments used in cancer inducing cardiovascular and metabolic side effects | Drug | – |
Primary outcome
Number of patients having a benefit after this specific cardio-oncology check up and follow up
Time frame: 5 years
14 secondary outcomes
Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments
Time frame: 5 years
All relevants staisticals associations between adverse events and anticancer drugs
Time frame: 5 years
All relevant statistical associations between cardiovascular toxicities, and anticancer drugs
Time frame: 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
Time frame: 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
Time frame: 5 years
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
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
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
All relevant statistical associations between metabolic toxicities, and anticancer drugs
Time frame: 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
Time frame: 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
Time frame: 5 years
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 31189043Salem 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.
- Derived from this study: PubMed 31988143Dolladille 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Complication and Cardiovascular Insufficiency, run by Groupe Hospitalier Pitie-Salpetriere at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joe-Elie Salem, MD, PhD ((0)1 42 17 85 33 ext. +33, joe-elie.salem@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients having a benefit after this specific cardio-oncology check up and follow up (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882580, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.