ctDNA analysis
Otherblood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable
NCT Number: NCT03926260
In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.
Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.
An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Marie MARCQ, La Roche-sur-Yon, France
The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable
Time frame: week 3 after patient's recruitment date (baseline)
Changes of the amount of ctDNA between baseline and week 3 will make it possible to determine the biological response: increase, stability or decrease in ctDNA.
Time frame: week 3 after baseline
Radiological assessment, based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1, will be: complete response, partial response, progression or stabilization. Biological response will be: increase, stability or decrease in ctDNA.
Time frame: progression
Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression
Time frame: progression
Biological response will be: increase, stability or decrease in ctDNA and Radiological response will be defined according to RECIST criteria v1.1 will be: complete or partial response
Time frame: week 3 after baseline
Radiological assessment, based on RECIST criteria v1.1, will be: complete response or partial response. Biological response will be: increase, stability or decrease in ctDNA.
Centre Hospitalier Departemental Vendee
Other
Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers
Acronym: ELUCID
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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