A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents

  • STATUS
    Recruiting
  • End date
    Dec 4, 2022
  • participants needed
    1500
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 4 March 2021

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.

Details
Condition Metastatic Oncogen-driven Cancer, Metastatic Oncogen-driven Cancer, Metastatic Oncogen-driven Cancer, Metastatic Oncogen-driven Cancer
Treatment biopsy
Clinical Study IdentifierNCT02517892
SponsorGustave Roussy, Cancer Campus, Grand Paris
Last Modified on4 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed with confirmed cancer and who fulfill the following
eligibility criteria will be considered eligible for this study
Patient affiliated to a social security regimen
Patients scheduled to receive anticancer agents or currently receiving anticancer agents
Tumor lesion accessible to core biopsies (malignant effusions can represent an alternative)
Patient who is fully informed, able to comply with the protocol and who signed the informed consent
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

Coagulation abnormality prohibiting a biopsy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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