Clinical trial NCT01723969: Screening Platform for Clinical Trials in Advanced Colorectal Cancer
Official title: Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Advanced Colorectal Cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2012-11-08
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic colo-rectal cancer

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.


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

Primary outcomes:
measure: Tumour markers assessment
timeFrame: Within 1 week after patient registration
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
city: Brussels
country: Belgium
facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: U.Z. Leuven - Campus Gasthuisberg
city: Stróvolos
country: Cyprus
facility: Bank Of Cyprus Oncology Centre
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Hamburg
country: Germany
facility: Universitaets-Krankenhaus Eppendorf
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Muenchen
country: Germany
facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern
city: Oldenburg
country: Germany
facility: Kliniken Oldenburg
city: Heraklion
country: Greece
facility: University General Hospital Heraklion
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro
city: Napoli
country: Italy
facility: Seconda Universita Degli Studi Di Napoli
city: Poznan
country: Poland
facility: The Great Poland Cancer Centre
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Centre
city: Lisboa
country: Portugal
facility: I.P.O. Francisco Gentil - Centro De Lisboa
city: Barcelona
country: Spain
facility: Hospital General Vall D'Hebron
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Goteborg
country: Sweden
facility: Ostra Sjukhuset
city: Geneva
country: Switzerland
facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Sion
country: Switzerland
facility: Hopital du Valais - Hopital de Sion
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zurich
Study officials:
affiliation: Universitaetsklinikum Carl Gustav Carus, Dresden, DE
name: Gunnar Folprecht, MD
role: STUDY_CHAIR
affiliation: U.Z. Leuven - Campus Gasthuisberg, Leuven, BE
name: Sabine Tejpar, MD, PhD
role: STUDY_CHAIR
affiliation: Universitaetsklinikum Carl Gustav Carus, Dresden, DE
name: Daniela Aust, MD
role: STUDY_CHAIR
References: