SCHISM: 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.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Melanoma
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| clear cell renal cancer
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| Urothelial Carcinoma of the bladder
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| squamous cell carcinomas of the head and neck
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| non-small cell lung cancer
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Outcome Measures
Primary Outcome Measures
- Interest of the plasmatic free circulating DNA (cfDNA) [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]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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No contraindications to immunotherapy
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Non-pregnant patient
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Patient not opposed to participation in this study
Exclusion Criteria:
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HIV seropositivity
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Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | APHM | Marseille | France |
Sponsors and Collaborators
- Assistance Publique Hopitaux De Marseille
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-048