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.

NCT05083494 | Unknown

• 1 other identifier: 2020-048
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Melanoma

clear cell renal cancer

Urothelial Carcinoma of the bladder

squamous cell carcinomas of the head and neck

non-small cell lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients starting a cancer treatment, as part of marketing treatment (alone or in combination) in five type of cancer (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).

You may qualify if:

• 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

You may not qualify if:

• HIV seropositivity
• Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

APHM

Marseille, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Sebastien Salas, Professor

CONTACT

sebastien.salas@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: April 9, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

FR (1)