Screening Platform for Clinical Trials in Advanced Colorectal Cancer

Overview

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.

Full Title of Study: “Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer “SPECTAcolor”"

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2019

Interventions

  • Genetic: Tumour markers testing
    • Tumour markers testing in patients advanced or metastatic colo-rectal cancer.

Arms, Groups and Cohorts

  • Colo-rectal cancer
    • Tumour markers testing in patients with advanced or metastatic colo-rectal cancer

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Organisation for Research and Treatment of Cancer – EORTC
  • Collaborator
    • Alliance Boots
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gunnar Folprecht, MD, Study Chair, Universitaetsklinikum Carl Gustav Carus, Dresden, DE
    • Sabine Tejpar, MD, PhD, Study Chair, U.Z. Leuven – Campus Gasthuisberg, Leuven, BE
    • Daniela Aust, MD, Study Chair, Universitaetsklinikum Carl Gustav Carus, Dresden, DE

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