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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01723969
Recruitment Status : Recruiting
First Posted : November 8, 2012
Last Update Posted : August 8, 2017
Alliance Boots
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Colorectal Cancer Advanced Colorectal Cancer Genetic: Tumour markers testing

Study Type : Observational
Estimated Enrollment : 2600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"
Study Start Date : September 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Tumour markers assessment [ Time Frame: Within 1 week after patient registration ]
    Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3

Biospecimen Retention:   Samples With DNA
FFPE blocks of tumour tissue

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01723969

Contact: Stefanie Schrauwen, MSc

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
Bank Of Cyprus Oncology Centre Recruiting
Strovolos - Nicosia, Cyprus, 2006
Gustave Roussy Cancer Campus Recruiting
Villejuif, France, 94805
Universitaetsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, DE 01307
Universitaets-Krankenhaus Eppendorf Recruiting
Hamburg, Germany, 20246
Universitaetsklinikum Leipzig Recruiting
Leipzig, Germany, DE 04205
Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern Recruiting
Muenchen, Germany, DE 81377
Kliniken Oldenburg Recruiting
Oldenburg, Germany, DE 26133
University General Hospital Heraklion Recruiting
Heraklion, Greece, GR 71110
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
The Great Poland Cancer Centre Recruiting
Poznan, Poland, PL 61 866
Maria Sklodowska-Curie Memorial Cancer Centre Recruiting
Warsaw, Poland, PL 02 781
I.P.O. Francisco Gentil - Centro De Lisboa Recruiting
Lisboa, Portugal, PT 1099-023
Hospital General Vall D'Hebron Recruiting
Barcelona, Spain, ES 08035
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals Recruiting
L'Hospitalet de Llobregat, Spain, ES 08907
Hospital Universitario San Carlos Recruiting
Madrid, Spain, ES 28040
Hospital Universitario 12 De Octubre Recruiting
Madrid, Spain, ES 28041
Ostra Sjukhuset Recruiting
Goteborg, Sweden, SE 41685
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie Recruiting
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
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
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

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT01723969     History of Changes
Other Study ID Numbers: EORTC-40CRC
2012-003714-14 ( EudraCT Number )
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

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