Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting PD-1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03313544|
Recruitment Status : Not yet recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Prospective, monocentric clinical study. Patients selected for nivolumab therapy in AP-HM for melanoma and non-small cell lung cancer will be eligible. Do not include patients with conditions that do not allow MRI, prior cardiovascular disease with LVEF<50%, cardiomyopathy, history of cardiac arrhythmia, history of cardiovascular toxicity under anticancer therapy, coronary artery disease or stroke less than 3 months Therapeutic management will not be modified and treatment will be administrated as usual.
Cardiovascular follow up will be identical to that recommended and realized in current care in the Cardio-Oncology unit of AP-HM. It will include clinical, biological (BNP and troponin) and trans-thoracic echocardiography (TTE) at baseline and then at 1, 3 and 6 months. Auto-antibodies against troponin I assay will be performed to avoid false negatives of normal blood level of troponin I at baseline and then at 6 months. Cardiac MRI will be performed as well at baseline and at the end of the study (6 months). MRI is the gold standard for ventricular function evaluation.
Primary endpoint will be left ventricular function evolution evaluated by global longitudinal strain (GLS, 2D speckles tracking) in TTE. Secondary endpoints will be left and right ventricular function parameters: LEVF by TTE and MRI, left ventricular indexed volumes by TTE and MRI, right ejection ventricular function and indexed volumes by TTE and MRI, systolic pulmonary arterial pressure by TTE, serum troponin I and BNP, arrhythmias and conduction disorders on the electrocardiogram (ECG).
Number of required subjects: GLS is recommended for following up left ventricular function under anticancer treatments. Based on the hypothesis of a significant GLS decrease (15%) in 20% of cases with alpha risk of 0.05 and accuracy of 0.12 which means expected confidence interval of 0.08-0.32, then the number of required subjects is 50 patients.
The inclusion period will be 18 months with a follow up if 6 months, ie a total duration of the study of 24 months.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non-small Cell Lung Cancer||Drug: Nivolumab Device: MRI Biological: BLOOD SAMPLES Device: trans-thoracic echocardiography||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting Programmed Cell Death 1 (PD-1)|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||March 2021|
|Experimental: NIVOLUMAB PATIENTS||
Cardiac MRI 6 MONTHS
Biological: BLOOD SAMPLES
biological (BNP and troponin)
Device: trans-thoracic echocardiography
1, 3 and 6 months
- systolic pulmonary arterial pressure [ Time Frame: 6 months ]trans-thoracic echocardiography
- ventricular function evaluation. [ Time Frame: 6 MONTHS ]MRI
- serum troponin I [ Time Frame: 1,3, 6 months ]BLOOD SAMPLES
- Brain natriuretic peptide (BNP) [ Time Frame: 1,3, 6 months ]BLOOD SAMPLES
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): NCT03313544
|Contact: jennifer CAUTELAfirstname.lastname@example.org|
|Contact: ALEXANDRA GIULIANIemail@example.com|
|Assistance Publique Hopitaux de Marseille||Not yet recruiting|
|Marseille, France, 13354|
|Contact: JENNIFER CAUTELA firstname.lastname@example.org|
|Principal Investigator: jennifer CAUTELA|
|Study Director:||Jean-Olivier ARNAUD||assistance publique hôpitaux de marseille|