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

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ClinicalTrials.gov Identifier: NCT01723969
Recruitment Status : Active, not recruiting
First Posted : November 8, 2012
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Alliance Boots
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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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 Design
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Study Type : Observational
Actual Enrollment : 668 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 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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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

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01723969


Locations
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Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Alliance Boots
Investigators
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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
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01723969    
Other Study ID Numbers: EORTC-40CRC
2012-003714-14 ( EudraCT Number )
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases