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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02517892
Other study ID # 2014-A01147-40
Secondary ID 2014/2144
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 18, 2014
Est. completion date March 2025

Study information

Verified date August 2023
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date March 2025
Est. primary completion date November 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biopsy


Locations

Country Name City State
France Gustave Roussy Cancer Campus Grand Paris Villejuif Val De Marne

Sponsors (1)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type and frequency of molecular alterations in resistant tumors using whole exome sequencing 30 days after inclusion