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RECRUITING
NCT04720339
NA

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

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2021-05-27

Completion Date

2027-10-27

Last Updated

2022-11-23

Healthy Volunteers

No

Interventions

GENETIC

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.

Locations (8)

CHU de Besancon - Service de pneumologie

Besançon, France

Hopitaux Civils de Colmar - service de Pneumologie

Colmar, France

CHU de Dijon - service de Pneumologie

Dijon, France

CLCC Georges-François Leclerc

Dijon, France

GHR Mulhouse Sud-Alsace - Service de Pneumologie

Mulhouse, France

CHU de Reims - service de Pneumologie

Reims, France

CHRU de Strasbourg

Strasbourg, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France