Clinical trial · Observational

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

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)

NCT02364024CI-TRIAL-00033657CD3-OncoQuantcompletedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastatic Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

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

Primary outcomes (1)

measure
Time to Recurrence (TTR)
timeFrame
2 years
description
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 (2)

measure
Overall Survival (OS)
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 74 Years

Show eligibility criteria text

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\- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study

References

Publications (2)

BACKGROUNDTaieb 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. PMID 24928083
RESULTEmile 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. PMID 28651158