Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA (ELUCID)
Primary Purpose
Metastatic Non-small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ctDNA analysis
Sponsored by
About this trial
This is an interventional other trial for Metastatic Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
- At least one measurable target according to RECIST criteria
- Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
- Performance Status 0 to 2
- Affiliated to a social security system
- Patient who can be followed under the protocol
- Patient agreed to participate in the study and gave his/her express consent
Exclusion Criteria:
- Minor
- Small cell or mixed bronchial cancer
- Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
- Patient who has already started a first line of treatment
- Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
- History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years
- Patient which, does present a substantial risk of recurrence.
- Major under guardianship, curators or deprived of liberty
- Pregnant or lactating woman, or of childbearing age without effective contraception
- Not affiliated to a social security system
- Inability to understand the protocol and / or to give express consent
Sites / Locations
- Marie MARCQ
- Jaafar BENNOUNA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ctDNA analysis
Arm Description
additional blood sample of 20 ml
Outcomes
Primary Outcome Measures
Biological response at week 3
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.
Secondary Outcome Measures
Progression-free survival (radiological assessment) and biological response at week 3.
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
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
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
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.
Full Information
NCT ID
NCT03926260
First Posted
April 16, 2019
Last Updated
June 28, 2022
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT03926260
Brief Title
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
Acronym
ELUCID
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
May 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ctDNA analysis
Arm Type
Experimental
Arm Description
additional blood sample of 20 ml
Intervention Type
Other
Intervention Name(s)
ctDNA analysis
Intervention Description
blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable
Primary Outcome Measure Information:
Title
Biological response at week 3
Description
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 patient's recruitment date (baseline)
Secondary Outcome Measure Information:
Title
Progression-free survival (radiological assessment) and biological response at week 3.
Description
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
week 3 after baseline
Title
biological progression and radiological progression
Description
Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression
Time Frame
progression
Title
biological response and radiological response
Description
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
progression
Title
Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy
Description
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.
Time Frame
week 3 after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
At least one measurable target according to RECIST criteria
Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
Performance Status 0 to 2
Affiliated to a social security system
Patient who can be followed under the protocol
Patient agreed to participate in the study and gave his/her express consent
Exclusion Criteria:
Minor
Small cell or mixed bronchial cancer
Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
Patient who has already started a first line of treatment
Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years
Patient which, does present a substantial risk of recurrence.
Major under guardianship, curators or deprived of liberty
Pregnant or lactating woman, or of childbearing age without effective contraception
Not affiliated to a social security system
Inability to understand the protocol and / or to give express consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc DENIS
Organizational Affiliation
CHD Vendee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marie MARCQ
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Jaafar BENNOUNA
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
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