Screening Platform for Clinical Trials in Advanced Colorectal Cancer

NCT01723969 | Completed DMC

• 2 other identifiers: EORTC-40CRC2012-003714-14
• Study Type: observational
• Target: 668
• Locations: 11 countries
• Sites: 27

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.

Conditions

Colorectal Cancer; Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Tumour markers assessment

  Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3

  Within 1 week after patient registration

Study Arms (1)

Colo-rectal cancer

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

Genetic: Tumour markers testing

Interventions

Tumour markers testing GENETIC

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

Colo-rectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced or metastatic colo-rectal cancer

You may qualify if:

• Colo-rectal cancer (advanced or metastatic)
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

You may not qualify if:

• Absence of patient's consent

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (27)

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

U.Z. Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Bank Of Cyprus Oncology Centre

Stróvolos, 2006, Cyprus

Location

Gustave Roussy Cancer Campus

Villejuif, 94805, France

Location

Universitaetsklinikum Carl Gustav Carus

Dresden, DE 01307, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, 20246, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, DE 04205, Germany

Location

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

München, DE 81377, Germany

Location

Kliniken Oldenburg

Oldenburg, DE 26133, Germany

Location

University General Hospital Heraklion

Heraklion, GR 71110, Greece

Location

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

Genova, 16132, Italy

Location

Seconda Universita Degli Studi Di Napoli

Napoli, 80138, Italy

Location

The Great Poland Cancer Centre

Poznan, PL 61 866, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Centre

Warsaw, PL 02 781, Poland

Location

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

Lisbon, PT 1099-023, Portugal

Location

Hospital General Vall D'Hebron

Barcelona, ES 08035, Spain

Location

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

L'Hospitalet de Llobregat, ES 08907, Spain

Location

Hospital Universitario San Carlos

Madrid, ES 28040, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, ES 28041, Spain

Location

Ostra Sjukhuset

Gothenburg, SE 41685, Sweden

Location

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

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Hopital du Valais - Hopital de Sion

Sion, CH 1951, Switzerland

Location

UniversitaetsSpital Zurich

Zurich, CH 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE blocks of tumour tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 8, 2012
• Study Start: September 1, 2013
• Primary Completion: April 10, 2019
• Study Completion: March 10, 2020
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

SE (1); FR (1); DE (5); IT (2); BE (5); GR (1); ES (4); PL (2); CH (4); CY (1); PT (1)