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A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents (MATCH-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517892
Recruitment Status : Recruiting
First Posted : August 7, 2015
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE August 3, 2015
First Posted Date  ICMJE August 7, 2015
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE December 18, 2014
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
Type and frequency of molecular alterations in resistant tumors using whole exome sequencing [ Time Frame: 30 days after inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents
Official Title  ICMJE A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents
Brief Summary

This is a prospective study to identify molecular mechanisms of acquired resistance to targeted therapies in patients with unresectable or metastatic cancer.

This is a protocol to study clinical characteristics and biopsy tissue of patients with oncogene-driven cancer who have had previous clinical response to targeted therapy and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of acquired resistance to targeted therapies.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Oncogen-driven Cancer
Intervention  ICMJE Procedure: Biopsy
Study Arms  ICMJE Experimental: Patients with metastatic oncogen-driven cancer
Intervention: Procedure: Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2021)
1500
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2015)
600
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients diagnosed with confirmed cancer and who fulfill the following eligibility criteria will be considered eligible for this study:

  1. Patient affiliated to a social security regimen
  2. Patients scheduled to receive anticancer agents or currently receiving anticancer agents
  3. Tumor lesion accessible to core biopsies (malignant effusions can represent an alternative)
  4. Patient who is fully informed, able to comply with the protocol and who signed the informed consent.
  5. Availability of initial tumor material (ideally frozen, or non-Bouin fixed paraffin embedded material) acquired before exposure to the targeted therapy Note: Patients may have received other treatments since treatment with targeted therapies including radiation or chemotherapy, before undergoing the study biopsy.

Exclusion Criteria:

1. Coagulation abnormality prohibiting a biopsy

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antoine ITALIANO, MD-PhD 0142114211 ext +33 antoine.italiano@gustaveroussy.fr
Contact: Aurélie Abou Lovergne 0142113862 ext +33 aurélie.aboulovergne@gustaveroussy.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02517892
Other Study ID Numbers  ICMJE 2014-A01147-40
2014/2144 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP