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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Collaborator:
Alliance Boots
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01723969
First received: November 5, 2012
Last updated: June 9, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention
Colorectal Cancer
Advanced Colorectal Cancer
Genetic: Tumour markers testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Tumour markers assessment [ Time Frame: Within 1 week after patient registration ] [ Designated as safety issue: No ]
    Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3


Biospecimen Retention:   Samples With DNA
FFPE blocks of tumour tissue

Estimated Enrollment: 2600
Study Start Date: September 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced or metastatic colo-rectal cancer
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723969

Contacts
Contact: Aline Gheeraert, MSc aline.gheeraert@eortc.be

Locations
Belgium
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme Recruiting
Brussels, Belgium, 1070
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
U.Z. Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Cyprus
Bank Of Cyprus Oncology Centre Recruiting
Strovolos - Nicosia, Cyprus, 2006
France
Gustave Roussy Cancer Campus Recruiting
Villejuif, France, 94805
Germany
Universitaetsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, DE 01307
Principal Investigator: Gunnar Folprecht, Pr.         
Klinik Fuer Tumorbiologie - Freiburg im Breisgau Recruiting
Freiburg IM BREISGAU, Germany, 79106
Universitaets-Krankenhaus Eppendorf Recruiting
Hamburg, Germany, 20246
Universitaetsklinikum Leipzig Recruiting
Leipzig, Germany, DE 04205
Principal Investigator: Florian Lordick, Pr.         
Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern Recruiting
Muenchen, Germany, DE 81377
Sub-Investigator: Dominik Modest, Dr         
Principal Investigator: Volker Heinemann, Pr         
Kliniken Oldenburg Recruiting
Oldenburg, Germany, DE 26133
Principal Investigator: Claus-Henning Koehne, Pr         
Greece
University General Hospital Heraklion Recruiting
Heraklion, Greece, GR 71110
Italy
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro Recruiting
Genova, Italy, 16132
Seconda Universita Degli Studi Di Napoli Recruiting
Napoli, Italy, 80138
Poland
The Great Poland Cancer Centre Recruiting
Poznan, Poland, PL 61 866
Maria Sklodowska-Curie Memorial Cancer Centre Recruiting
Warsaw, Poland, PL 02 781
Portugal
I.P.O. Francisco Gentil - Centro De Lisboa Recruiting
Lisboa, Portugal, PT 1099-023
Spain
Hospital General Vall D'Hebron Recruiting
Barcelona, Spain, ES 08035
Principal Investigator: Josep Tabernero, Pr         
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals Recruiting
L'Hospitalet de Llobregat, Spain, ES 08907
Principal Investigator: Ramon Salazar, Pr         
Hospital Universitario San Carlos Recruiting
Madrid, Spain, ES 28040
Hospital Universitario 12 De Octubre Recruiting
Madrid, Spain, ES 28041
Sweden
Ostra Sjukhuset Recruiting
Goteborg, Sweden, SE 41685
Switzerland
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie Recruiting
Geneva, Switzerland, CH-1211
Contact: Arnaud Roth    022-372-77-43      
Principal Investigator: Arnaud Roth, Pr.         
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Contact Person    41-21-314-1111      
Principal Investigator: Anna Dorothea Wagner, Dr         
Hopital du Valais - Hopital de Sion Recruiting
Sion, Switzerland, CH 1951
UniversitaetsSpital Zurich Recruiting
Zurich, Switzerland, CH 8091
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Alliance Boots
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
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01723969     History of Changes
Other Study ID Numbers: EORTC-40CRC  2012-003714-14 
Study First Received: November 5, 2012
Last Updated: June 9, 2016
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on December 02, 2016