PETACC-8 miR-31-3p and miR-31-5p Ancillary Study

Last updated: December 4, 2017
Sponsor: IntegraGen SA
Overall Status: Completed

Phase

3

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT03362684
IG2017001
  • Ages 18-74
  • All Genders

Study Summary

This is a prospective-retrospective study to determine if the expression of the miRNA's miR-31-3p and miR-31-5p are prognostic of patient outcomes or predictive of the benefit from anti-EGFR therapy in stage III Colon Cancer. The present study will utilize FFPE tumor samples collected from patients enrolled in the PETACC-8 study conducted by the Fédération Francophone de Cancérologie Digestive (FFCD). This phase 3 clinical trial prospectively randomized fully resected stage III colon cancer patients to receive adjuvant treatment with either FOLFOX-4 plus cetuximab or FLOFOX-4 alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient included in PETACC08 study

  • Signed informed consent for translational study

  • FFPE tumor sample available for miR-31-3p and miR-31-5p expression testing

Exclusion

Exclusion Criteria:

  • Patient who have withdrawn their consent for PETACC08 and/or for PETACC08translational study

Study Design

Total Participants: 1808
Study Start date:
November 01, 2005
Estimated Completion Date:
June 30, 2016