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

NCT ID: NCT02364024

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

856 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

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

No interventions assigned to this group

Arm B

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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\- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emile Jean-François, Pr

Role: STUDY_DIRECTOR

Fédération Fancophone de Cancérologie Digestive

References

Explore related publications, articles, or registry entries linked to this study.

Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.

Reference Type BACKGROUND
PMID: 24928083 (View on PubMed)

Emile JF, Julie C, Le Malicot K, Lepage C, Tabernero J, Mini E, Folprecht G, Van Laethem JL, Dimet S, Boulagnon-Rombi C, Allard MA, Penault-Llorca F, Bennouna J, Laurent-Puig P, Taieb J; PETACC8 Study Investigators; Austrian Breast and Colorectal cancer Study Group (ABCSG); Belgian Group of Digestive Oncology (BGDO); Lone Norgard Petersen; Federation Francophone de Cancerologie Digestive (FFCD); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Federation Nationale des Centres de Lutte Contre le Cancer Association Europeenne de Recherche en Oncologie (AERO); Arbeitsgemeinschaft Internistische Onkologie (AIO); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico dell'Italia Meridionale (GOIM); Istituto Oncologico Romagnolo (IOR); Gruppo Cooperativo Chirurgico Italiano (GOCCI); Gruppo Oncologico Nord Ovest (GONO); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC); Gruppo Cooperativo do Cancro Digestivo da Associacao Portuguesa de Investigacao Oncologica (GCCD, APIO); Grupo Espanol para el Tratamiento de los Tumores Digestivos (TTD); John Allen Bridgewater. Prospective validation of a lymphocyte infiltration prognostic test in stage III colon cancer patients treated with adjuvant FOLFOX. Eur J Cancer. 2017 Sep;82:16-24. doi: 10.1016/j.ejca.2017.04.025. Epub 2017 Jun 23.

Reference Type RESULT
PMID: 28651158 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PETACC8-BIO1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.