ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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.


Condition or disease Intervention/treatment Phase
Metastatic Oncogen-driven Cancer Procedure: Biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents
Study Start Date : December 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Patients with metastatic oncogen-driven cancer Procedure: Biopsy



Primary Outcome Measures :
  1. Type and frequency of molecular alterations in resistant tumors using whole exome sequencing [ Time Frame: 30 days after inclusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

  1. Patient affiliated to a social security regimen
  2. Therapy with a targeted agent (as defined in appendix 1).
  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


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): NCT02517892


Contacts
Contact: Jean Charles Soria, MD-PhD 0142114291 ext +33 soria@gustaveroussy.fr
Contact: Aurélie Abou Lovergne 0142113862 ext +33 aurélie.aboulovergne@gustaveroussy.fr

Locations
France
Gustave Roussy Cancer Campus Grand Paris Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Jean Charles ² Soria, MD-PhD    0142114391 ext +33    soria@gustaveroussy.fr   
Contact: Aurélie Abou Lovergne    0142113862 ext +33    aurelie.aboulovergne@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02517892     History of Changes
Other Study ID Numbers: 2014-A01147-40
2014/2144 ( Other Identifier: CSET number )
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017