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

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: Colorectal Cancer; Advanced Colorectal Cancer
• Intervention / Treatment: Genetic: Tumour markers testing

• Study Type: Observational
• Enrollment (Actual): 668

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium, 1000
    • Hôpitaux 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 Zurich

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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

Collaborators and Investigators

• 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

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: EORTC-40CRC; 2012-003714-14 (EUDRACT_NUMBER)