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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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.


Condition or disease Intervention/treatment Phase
Metastatic Non-small Cell Lung Cancer Other: ctDNA analysis Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Agnes DORION 2.51.44.63.80 ext +33 agnes.dorion@chd-vendee.fr

Locations
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France
Marie MARCQ Recruiting
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         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Principal Investigator: Marc DENIS CHD Vendee
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03926260    
Other Study ID Numbers: CHD 160-18
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms