Screening Platform for Clinical Trials in Advanced Colore... | NCT01723969

ID	Type	Description	Link
2012-003714-14	EudraCT Number

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013Actual

Primary Completion Date

Apr 10, 2019Actual

Completion Date

Mar 10, 2020Actual

First Submitted Date

Nov 5, 2012

First Submission Date that Met QC Criteria

Nov 6, 2012

First Posted Date

Nov 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2022

Last Update Posted Date

Jul 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

668Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colo-rectal cancer		Tumour markers testing in patients with advanced or metastatic colo-rectal cancer	Genetic: Tumour markers testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tumour markers testing	Genetic	Tumour markers testing in patients advanced or metastatic colo-rectal cancer.	Colo-rectal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumour markers assessment	Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3	Within 1 week after patient registration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced or metastatic colo-rectal cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet		Brussels		1000	Belgium
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases