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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.

NCT ID: NCT05083494

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-09

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Melanoma

No interventions assigned to this group

clear cell renal cancer

No interventions assigned to this group

Urothelial Carcinoma of the bladder

No interventions assigned to this group

squamous cell carcinomas of the head and neck

No interventions assigned to this group

non-small cell lung cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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APHM

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sebastien Salas, Professor

Role: CONTACT

[email protected]

Facility Contacts

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Sebastien Salas, MD

Role: primary

[email protected]

Other Identifiers

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2020-048

Identifier Type: -

Identifier Source: org_study_id