Validation Study of Linear Quantification of CD3+ Cells in Localized Colorectal Carcinomas

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Treatment and study plan

Primary outcomes

Time to Recurrence (TTR)

Time frame: 2 years

TTR is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or death due to disease recurrence) whichever occured first or last follow-up ( Last news for patients without event (censored data))

Secondary outcomes

Overall Survival (OS)

Time frame: until death

Overall survival is defined as the time from randomization to death any cause or last follow-up news (censored data).
Disease-Free Survival (DFS)

Time frame: 2 years

DFS is defined by the time between randomisation and the first event occured (Local or metastatic recurrence or second cancer or death (all causes)) whichever occured first or last follow-up ( Last news for patients without event (censored data))

Sponsors and collaborators

Lead sponsor

Federation Francophone de Cancerologie Digestive

Other

Registry information

Official study title

Biomarker Validation Study of Linear Quantification of CD3 Positive Cells in Localized Colorectal Carcinomas, Based on the Cohort of Patient Included in PETACC8 International Phase III Trial (NCT00265811)

Acronym: CD3-OncoQuant

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2017
First posted: Feb 16, 2015
Registry last updated: Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed