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NCT05083494 Clinical Trial

Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.

Cancer Clinical Trial

— SCHISM  

Official title:
Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05083494
Other study ID # 2020-048
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 9, 2021
Est. completion date April 2024

Study information
Verified date October 2021
Source Assistance Publique Hopitaux De Marseille
Contact Sebastien Salas, Professor
Email sebastien.salas@ap-hm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established. The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.

Recruitment information / eligibility
Status Recruiting
Enrollment 260
Est. completion date April 2024
Est. primary completion date April 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients starting anti-PD1 immunotherapy as part of marketing authorization alone or in combination (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer). - No contraindications to immunotherapy - Non-pregnant patient - Patient not opposed to participation in this study Exclusion Criteria: - HIV seropositivity - Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France APHM Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Interest of the plasmatic free circulating DNA (cfDNA) The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence
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