Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

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

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2027-10-27

Brief Summary

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Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available.

The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA.

The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.

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Detailed Description

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Conditions

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NSCLC IMMUNOTHERAPY QUANTIFICATION OF CELL-FREE DNA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental arm

Group Type EXPERIMENTAL

Molecular monitoring by quantification of cell-free DNA

Intervention Type GENETIC

Molecular monitoring by quantification of cell-free DNA (absolute value and variation from baseline) of two house-keeping genes (RPP30, TMEM11) by droplet digital PCR, during based-immunotherapy treatments of NSCLC patients.

Cell-free DNA will be extracted from 4 ml of plasma before treatments by immunotherapy, obtained from blood Streck® tubes.

Quantification of house-keeping genes (or mutated genes if some are previously routinely identified in tumor tissue) by ddPCR.

Interventions

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Molecular monitoring by quantification of cell-free DNA

Molecular monitoring by quantification of cell-free DNA (absolute value and variation from baseline) of two house-keeping genes (RPP30, TMEM11) by droplet digital PCR, during based-immunotherapy treatments of NSCLC patients.

Cell-free DNA will be extracted from 4 ml of plasma before treatments by immunotherapy, obtained from blood Streck® tubes.

Quantification of house-keeping genes (or mutated genes if some are previously routinely identified in tumor tissue) by ddPCR.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* age over 18
* informed of the objectives of the project and signed consent
* non small cell lung cancer, stage IIIA, IIIB or IV
* PS (WHO performance status) \< or =2
* treatment based on immunotherapy (monotherapy or combination)
* at least one measurable target
* available results of PD-L1 expression