Screening Platform for Clinical Trials in Advanced Colorectal Cancer

NCT ID: NCT01723969

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

668 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2020-03-10

Brief Summary

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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

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Conditions

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Colorectal Cancer Advanced Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Colo-rectal cancer

Tumour markers testing in patients with advanced or metastatic colo-rectal cancer

Tumour markers testing

Intervention Type GENETIC

Tumour markers testing in patients advanced or metastatic colo-rectal cancer.

Interventions

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Tumour markers testing

Tumour markers testing in patients advanced or metastatic colo-rectal cancer.

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Folprecht, MD

Role: STUDY_CHAIR

Universitaetsklinikum Carl Gustav Carus, Dresden, DE

Sabine Tejpar, MD, PhD

Role: STUDY_CHAIR

U.Z. Leuven - Campus Gasthuisberg, Leuven, BE

Daniela Aust, MD

Role: STUDY_CHAIR

Universitaetsklinikum Carl Gustav Carus, Dresden, DE

Locations

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Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

Brussels, , Belgium

Site Status

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

Brussels, , Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status

U.Z. Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status

Bank Of Cyprus Oncology Centre

Stróvolos, , Cyprus

Site Status

Gustave Roussy Cancer Campus

Villejuif, , France

Site Status

Universitaetsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Universitaets-Krankenhaus Eppendorf

Hamburg, , Germany

Site Status

Universitaetsklinikum Leipzig

Leipzig, , Germany

Site Status

Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

München, , Germany

Site Status

Kliniken Oldenburg

Oldenburg, , Germany

Site Status

University General Hospital Heraklion

Heraklion, , Greece

Site Status

IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro

Genova, , Italy

Site Status

Seconda Universita Degli Studi Di Napoli

Napoli, , Italy

Site Status

The Great Poland Cancer Centre

Poznan, , Poland

Site Status

Maria Sklodowska-Curie Memorial Cancer Centre

Warsaw, , Poland

Site Status

I.P.O. Francisco Gentil - Centro De Lisboa

Lisbon, , Portugal

Site Status

Hospital General Vall D'Hebron

Barcelona, , Spain

Site Status

Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, , Spain

Site Status

Hospital Universitario San Carlos

Madrid, , Spain

Site Status

Hospital Universitario 12 De Octubre

Madrid, , Spain

Site Status

Ostra Sjukhuset

Gothenburg, , Sweden

Site Status

Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

Geneva, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Hopital du Valais - Hopital de Sion

Sion, , Switzerland

Site Status

UniversitaetsSpital Zurich

Zurich, , Switzerland

Site Status

Countries

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Belgium Cyprus France Germany Greece Italy Poland Portugal Spain Sweden Switzerland

Other Identifiers

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2012-003714-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-40CRC

Identifier Type: -

Identifier Source: org_study_id

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