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Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
Sponsor: University Hospital, Strasbourg, France
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
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