Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Molecular monitoring by quantification of cell-free DNA.
- Who it may be relevant to
- Registry conditions: NSCLC, IMMUNOTHERAPY, QUANTIFICATION OF CELL-FREE DNA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Predictive value of quantification of cell-free DNA from plasma at the time of the first radiological evaluation, on clinical benefit [Time frame: Inclusion visit - visit 2 (day 60)]
Secondary outcome measures (1)
- Study of 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. [Time frame: Inclusion visit, visit 1 (day 15), visit 2 (day 60), visit 3 (day 180), visit 4 (day 270), visit 5 (day 360), visit 6 (day 720), or early termination visit (in case of progression with end of immunotherapy)]
Eligibility criteria
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
Exclusion criteria
- concomitant other type of cancer
- another cancer in the last 5 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 8 centers
- CHU de Besancon - Service de pneumologie — Besançon
- Hopitaux Civils de Colmar - service de Pneumologie — Colmar
- CHU de Dijon - service de Pneumologie — Dijon
- CLCC Georges-François Leclerc — Dijon
- GHR Mulhouse Sud-Alsace - Service de Pneumologie — Mulhouse
- CHU de Reims - service de Pneumologie — Reims
- CHRU de Strasbourg — Strasbourg
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT04720339 · 7652