Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
Recruiting now · Not applicable
Conditions studied: NSCLC, IMMUNOTHERAPY, QUANTIFICATION OF CELL-FREE DNA
In brief
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 facts
- Study ID
- NCT04720339
- Run by
- University Hospital, Strasbourg, France
- People needed
- 250
- Starts
- 2021-05-27
- Expected to finish
- 2027-10-27
- Last updated by the study team
- 2022-11-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- concomitant other type of cancer
- another cancer in the last 5 years
Where it is running
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (enrolling)
- Hopitaux Civils de Colmar - service de Pneumologie — Colmar, France (enrolling)
- CHU de Dijon - service de Pneumologie — Dijon, France (enrolling)
- CHU de Besancon - Service de pneumologie — Besançon, France (enrolling)
- GHR Mulhouse Sud-Alsace - Service de Pneumologie — Mulhouse, France (enrolling)
- CHU de Reims - service de Pneumologie — Reims, France (enrolling)
- CHRU de Strasbourg — Strasbourg, France (enrolling)
- CLCC Georges-François Leclerc — Dijon, France
Full record on ClinicalTrials.gov
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