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

July 4, 2018 updated by: Federation Francophone de Cancerologie Digestive

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)

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

856

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patient of both gender who have underwent surgical resection of stage III colorectal carcinoma

Description

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- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Arm A
Patients with no or low immune response (score 1 or 2) with linear quantification of CD3+ cells
Arm B
Patients with high immune response (score 3 or 4) with linear quantification of CD3+ cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
until death
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))
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Study Director: Emile Jean-François, Pr, Fédération Fancophone de Cancérologie Digestive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETACC8-BIO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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