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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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 5, 2012
First Posted Date November 8, 2012
Last Update Posted Date June 21, 2019
Study Start Date September 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2012)
Tumour markers assessment [ Time Frame: Within 1 week after patient registration ]
Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Screening Platform for Clinical Trials in Advanced Colorectal Cancer
Official Title Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
FFPE blocks of tumour tissue
Sampling Method Non-Probability Sample
Study Population Patients with advanced or metastatic colo-rectal cancer
Condition
  • Colorectal Cancer
  • Advanced Colorectal Cancer
Intervention Genetic: Tumour markers testing
Tumour markers testing in patients advanced or metastatic colo-rectal cancer.
Study Groups/Cohorts Colo-rectal cancer
Tumour markers testing in patients with advanced or metastatic colo-rectal cancer
Intervention: Genetic: Tumour markers testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 20, 2019)
668
Original Estimated Enrollment
 (submitted: November 6, 2012)
2600
Estimated Study Completion Date February 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Cyprus,   France,   Germany,   Greece,   Italy,   Poland,   Portugal,   Spain,   Sweden,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01723969
Other Study ID Numbers EORTC-40CRC
2012-003714-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators 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
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date June 2019