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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 January 2014 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: January 22, 2014
Last verified: January 2014
  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
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: Michel Praet michel.praet@eortc.be

Locations
Germany
Universitaetsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, DE 01307
Principal Investigator: Gunnar Folprecht, Pr.         
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         
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         
Switzerland
Hopital Cantonal Universitaire de Geneva 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         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Alliance Boots
  More Information

No publications provided

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: January 22, 2014
Health Authority: Germany: Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz

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

ClinicalTrials.gov processed this record on November 19, 2014