Validation Study of Linear Quantification of CD3+ Cells in Localized Colorectal Carcinomas (CD3-OncoQuant)

Federation Francophone de Cancerologie Digestive

Status: Completed

Conditions: Metastatic Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02364024

PETACC8-BIO1

Details and patient eligibility

About

The purpose of this study is to confirm that linear quantification of CD3+ cells is a prognostic biomarker in localized colorectal carcinomas.

Full description

Adult patients of both gender who have underwent surgical resection of stage III colorectal carcinoma and randomised to receive a chemotherapy FOLFOX or FOLFOX + Cetuximab in the PETACC8 trial.

Enrollment: 856 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient included in PETACC08 study
• Signed informed consent for translational study
• FFPE tumor sample available for CD3 staining

Exclusion criteria

• Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Trial design

856 participants in 2 patient groups

Arm A

Description:

Patients with no or low immune response (score 1 or 2) with linear quantification of CD3+ cells

Arm B

Description:

Patients with high immune response (score 3 or 4) with linear quantification of CD3+ cells