Screening Platform for Clinical Trials in Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

— SPECTAcolor  

Official title:

Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723969
• Other study ID #: EORTC-40CRC
• Secondary ID: 2012-003714-14
• Status: Completed
• Start date: September 2013
• Est. completion date: March 10, 2020

Study information

• Verified date: July 2022
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 668
• Est. completion date: March 10, 2020
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme	Brussels
Belgium	Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Leuven - Campus Gasthuisberg	Leuven
Cyprus	Bank Of Cyprus Oncology Centre	Stróvolos
France	Gustave Roussy Cancer Campus	Villejuif
Germany	Universitaetsklinikum Carl Gustav Carus	Dresden
Germany	Universitaets-Krankenhaus Eppendorf	Hamburg
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern	Muenchen
Germany	Kliniken Oldenburg	Oldenburg
Greece	University General Hospital Heraklion	Heraklion
Italy	IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro	Genova
Italy	Seconda Universita Degli Studi Di Napoli	Napoli
Poland	The Great Poland Cancer Centre	Poznan
Poland	Maria Sklodowska-Curie Memorial Cancer Centre	Warsaw
Portugal	I.P.O. Francisco Gentil - Centro De Lisboa	Lisboa
Spain	Hospital General Vall D'Hebron	Barcelona
Spain	Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals	L'Hospitalet de Llobregat
Spain	Hospital Universitario 12 De Octubre	Madrid
Spain	Hospital Universitario San Carlos	Madrid
Sweden	Ostra Sjukhuset	Goteborg
Switzerland	Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Hopital du Valais - Hopital de Sion	Sion
Switzerland	UniversitaetsSpital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Cyprus,  France,  Germany,  Greece,  Italy,  Poland,  Portugal,  Spain,  Sweden,  Switzerland, 

Outcome

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