Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA (ELUCID)
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|ClinicalTrials.gov Identifier: NCT03926260|
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 12, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non-small Cell Lung Cancer||Other: ctDNA analysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 27, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||February 2023|
Experimental: ctDNA analysis
additional blood sample of 20 ml
Other: ctDNA analysis
blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable
- Biological response at week 3 [ 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.
- Progression-free survival (radiological assessment) and biological response at week 3. [ 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.
- biological progression and radiological progression [ Time Frame: progression ]Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression
- biological response and radiological response [ 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
- Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926260
|Contact: Agnes DORION||184.108.40.206.80 ext +email@example.com|
|La Roche-sur-Yon, France, 85000|
|Contact: Agnes DORION|
|Principal Investigator: Marie MARCQ, PH|
|Jaafar BENNOUNA||Not yet recruiting|
|Nantes, France, 44000|
|Contact: Agnes DORION|
|Principal Investigator: Jaafar BENNOUNA, PH|
|Principal Investigator:||Marc DENIS||CHD Vendee|