Cardiovascular PrognosisGMEDICONCT03492528
Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
A study testing blood samples in people with Cardiovascular Prognosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Prognosis
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2019to Oct 2027
- Phase
- Interventional
- 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
Who may be able to join
- All adults referred for specialist cardio-oncology consultations before the initiation of a cancer treatment according to pre-established indications will be eligible.
Who cannot join
- Failure to provide information that makes it impossible to complete a consultation form or refuse to sign the consent.
- Minor or major patient under guardianship
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assiatnce Publique Hopitaux de Marseille
Marseille, 13354
FRANCK THUNY, franck.thuny@ap-hm.fr
About this study
The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer.
This unique organization makes it possible to envisage the creation of a large cohort from which the incidence and predictive factors of cardiovascular toxicity can be determined.
Read more
Primary objective: to determine the cardiovascular prognosis of patients treated for cancer and followed up in cardio-oncology.
Secondary objectives
- To determine the clinical, biological and imaging factors associated with cardiovascular events under cancer treatment, in order to define a risk score including clinical, biological (biomarker) and imaging data.
- To create a biological source for testing other biomarkers and conducting genome-wide association studies and genetic factors associated with cardiovascular events under cancer treatment.
Read the detailed description
Each patient will be monitored for 5 years. Cardio-oncological follow-up and management within these centers will follow a common protocol established and validated in March 2016 on the basis of international recommendations and summaries of the characteristics produced for each drug. Additional blood samples will be taken for the biobanking. Depending on the case, a small skin biopsy will be carried out to analyze the cardiovascular response of in vitro immunotherapy using a reprogramming model of fibroblasts in hiPSC hiPSC (human induced Pluripotent Stem cells)-cardiomyocytes.
- Conditions
- Cardiovascular Prognosis
- Being tested
- blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
blood samples
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular patients treated for a cancer | Experimental | Not described Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of cardiac biomarkers
dosage of troponine
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 posted10 Apr 2018
- Study start5 Jul 2019
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular PrognosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-olivier ARNAUD, Study director, Assistance Publique-Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492528
- Sponsor's protocol ID
- 2017-50
- Other IDs
- 2017-A03362-51
- Acronym
- GMEDICO
- Status last verified
- Sep 2022
- First submitted
- 3 Apr 2018
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31988143
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"
- ClinicalTrials.gov ID
- NCT03492528
- Acronym / sponsor ID
- GMEDICO / 2017-50
- Conditions
- Cardiovascular Prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Apr 2018 (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.
The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer.
This unique organization makes it possible to envisage the creation of a large cohort from which the incidence and predictive factors of cardiovascular toxicity can be determined.
Primary objective: to determine the cardiovascular prognosis of patients treated for cancer and followed up in cardio-oncology.
Secondary objectives
- To determine the clinical, biological and imaging factors associated with cardiovascular events under cancer treatment, in order to define a risk score including clinical, biological (biomarker) and imaging data.
- To create a biological source for testing other biomarkers and conducting genome-wide association studies and genetic factors associated with cardiovascular events under cancer treatment.
Detailed description
Each patient will be monitored for 5 years. Cardio-oncological follow-up and management within these centers will follow a common protocol established and validated in March 2016 on the basis of international recommendations and summaries of the characteristics produced for each drug. Additional blood samples will be taken for the biobanking. Depending on the case, a small skin biopsy will be carried out to analyze the cardiovascular response of in vitro immunotherapy using a reprogramming model of fibroblasts in hiPSC hiPSC (human induced Pluripotent Stem cells)-cardiomyocytes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular patients treated for a cancer | Experimental | Biological: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults referred for specialist cardio-oncology consultations before the initiation of a cancer treatment according to pre-established indications will be eligible.
Key exclusion criteria (3 listed)
- Failure to provide information that makes it impossible to complete a consultation form or refuse to sign the consent.
- Minor or major patient under guardianship
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| blood samplesblood samples | Biological | Cardiovascular patients treated for a cancer |
Primary outcome
Dosage of cardiac biomarkers
Time frame: 5 YEARS
dosage of troponine
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 21 Sep 2022.
- 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.
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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.
jean-olivier ARNAUD study director
Assistance Publique-Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Cardiovascular Prognosis, run by Assistance Publique Hopitaux De Marseille at 1 site 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 1 inclusion and 3 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 franck thuny (33(0)4 91 96 86 83, franck.thuny@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of cardiac biomarkers (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 NCT03492528, which also lists 1 linked publication.
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 21 Sep 2022.