Screening Platform for Clinical Trials in Advanced Colorectal Cancer

Completed

• Conditions: Colorectal Cancer; Advanced Colorectal Cancer

• Registration Number: NCT01723969
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials.

Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients.

A major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients.

The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-08
• Study Start: 2013-09
• Primary Completion: 2019-04-10
• Study Completion: 2020-03-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

• Colo-rectal cancer (advanced or metastatic)
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria

• Absence of patient's consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumour markers assessment	Within 1 week after patient registration	Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3

Trial Locations

Locations (27)

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

U.Z. Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Bank Of Cyprus Oncology Centre; 🇨🇾 Stróvolos, Cyprus

Gustave Roussy Cancer Campus; 🇫🇷 Villejuif, France

Universitaetsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Universitaets-Krankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

Universitaetsklinikum Leipzig; 🇩🇪 Leipzig, Germany

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