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Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting PD-1

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ClinicalTrials.gov Identifier: NCT03313544
Recruitment Status : Not yet recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE October 18, 2017
Last Update Posted Date October 18, 2017
Estimated Study Start Date  ICMJE October 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
systolic pulmonary arterial pressure [ Time Frame: 6 months ]
trans-thoracic echocardiography
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting PD-1
Official Title  ICMJE Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting Programmed Cell Death 1 (PD-1)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Melanoma
  • Non-small Cell
  • Lung Cancer
Intervention  ICMJE
  • Drug: Nivolumab
    NIVOLUMAB
  • Device: MRI
    Cardiac MRI 6 MONTHS
  • Biological: BLOOD SAMPLES
    biological (BNP and troponin)
  • Device: trans-thoracic echocardiography
    1, 3 and 6 months
Study Arms  ICMJE Experimental: NIVOLUMAB PATIENTS
Interventions:
  • Drug: Nivolumab
  • Device: MRI
  • Biological: BLOOD SAMPLES
  • Device: trans-thoracic echocardiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

patients treated with nivolumab

Exclusion Criteria:

  • Age <18 years
  • Preliminary cardiac disease with FeVG <50%
  • Cardiomyopathy dilated, hypertrophic or restrictive
  • History of cardiac arrhythmia
  • History of cardiac toxicity under another anti-cancer treatment
  • Known coronary disease
  • History of stroke less than 3 months old
  • Patient not wishing to participate in the study
  • Vulnerable persons (pregnant women, adults under guardianship or guardianship, persons deprived of their liberty)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: jennifer CAUTELA 0491968289 jennifer.cautela@ap-hm.fr
Contact: ALEXANDRA GIULIANI 0491382747 drci@ap-hm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03313544
Other Study ID Numbers  ICMJE 2017-01
2017-001197-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean-Olivier ARNAUD assistance publique hôpitaux de marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP