Screening Platform for Clinical Trials in Advanced Colorectal Cancer (SPECTAcolor)

July 1, 2022 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

668

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
      • Brussels, Belgium, 1070
        • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, 3000
        • U.Z. Leuven - Campus Gasthuisberg
  • Cyprus
      • Stróvolos, Cyprus, 2006
        • Bank Of Cyprus Oncology Centre
  • France
      • Villejuif, France, 94805
        • Gustave Roussy Cancer Campus
  • Germany
      • Dresden, Germany, DE 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Hamburg, Germany, 20246
        • Universitaets-Krankenhaus Eppendorf
      • Leipzig, Germany, DE 04205
        • Universitaetsklinikum Leipzig
      • Muenchen, Germany, DE 81377
        • Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern
      • Oldenburg, Germany, DE 26133
        • Kliniken Oldenburg
  • Greece
      • Heraklion, Greece, GR 71110
        • University General Hospital Heraklion
  • Italy
      • Genova, Italy, 16132
        • IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro
      • Napoli, Italy, 80138
        • Seconda Università degli Studi di Napoli
  • Poland
      • Poznan, Poland, PL 61 866
        • The Great Poland Cancer Centre
      • Warsaw, Poland, PL 02 781
        • Maria Sklodowska-Curie Memorial Cancer Centre
  • Portugal
      • Lisboa, Portugal, PT 1099-023
        • I.P.O. Francisco Gentil - Centro De Lisboa
  • Spain
      • Barcelona, Spain, ES 08035
        • Hospital General Vall D'Hebron
      • L'Hospitalet de Llobregat, Spain, ES 08907
        • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
      • Madrid, Spain, ES 28040
        • Hospital Universitario San Carlos
      • Madrid, Spain, ES 28041
        • Hospital Universitario 12 de Octubre
  • Sweden
      • Goteborg, Sweden, SE 41685
        • Östra sjukhuset
  • Switzerland
      • Geneva, Switzerland, CH-1211
        • Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
      • Lausanne, Switzerland, CH-1011
        • Centre hospitalier universitaire vaudois
      • Sion, Switzerland, CH 1951
        • Hopital du Valais - Hopital de Sion
      • Zurich, Switzerland, CH 8091
        • Universitaetsspital Zürich

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced or metastatic colo-rectal cancer

Description

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 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
Intervention / Treatment
Colo-rectal cancer
Tumour markers testing in patients with advanced or metastatic colo-rectal cancer
Genetic: Tumour markers testing
Tumour markers testing in patients advanced or metastatic colo-rectal cancer.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Gunnar Folprecht, MD, Universitaetsklinikum Carl Gustav Carus, Dresden, DE
  • Study Chair: Sabine Tejpar, MD, PhD, U.Z. Leuven - Campus Gasthuisberg, Leuven, BE
  • Study Chair: Daniela Aust, MD, Universitaetsklinikum Carl Gustav Carus, Dresden, DE

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 (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

April 10, 2019

Study Completion (ACTUAL)

March 10, 2020

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (ESTIMATE)

November 8, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-40CRC
  • 2012-003714-14 (EUDRACT_NUMBER)

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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