Screening Platform for Clinical Trials in Advanced Colorectal Cancer (SPECTAcolor)

July 1, 2022 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
668

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Brussels, Belgium, 1000
        • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
      • Brussels, Belgium, 1070
        • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, 3000
        • U.Z. Leuven - Campus Gasthuisberg
  • Cyprus
      • Stróvolos, Cyprus, 2006
        • Bank Of Cyprus Oncology Centre
  • France
      • Villejuif, France, 94805
        • Gustave Roussy Cancer Campus
  • Germany
      • Dresden, Germany, DE 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Hamburg, Germany, 20246
        • Universitaets-Krankenhaus Eppendorf
      • Leipzig, Germany, DE 04205
        • Universitaetsklinikum Leipzig
      • Muenchen, Germany, DE 81377
        • Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern
      • Oldenburg, Germany, DE 26133
        • Kliniken Oldenburg
  • Greece
      • Heraklion, Greece, GR 71110
        • University General Hospital Heraklion
  • Italy
      • Genova, Italy, 16132
        • IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro
      • Napoli, Italy, 80138
        • Seconda Università degli Studi di Napoli
  • Poland
      • Poznan, Poland, PL 61 866
        • The Great Poland Cancer Centre
      • Warsaw, Poland, PL 02 781
        • Maria Sklodowska-Curie Memorial Cancer Centre
  • Portugal
      • Lisboa, Portugal, PT 1099-023
        • I.P.O. Francisco Gentil - Centro De Lisboa
  • Spain
      • Barcelona, Spain, ES 08035
        • Hospital General Vall D'Hebron
      • L'Hospitalet de Llobregat, Spain, ES 08907
        • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
      • Madrid, Spain, ES 28040
        • Hospital Universitario San Carlos
      • Madrid, Spain, ES 28041
        • Hospital Universitario 12 de Octubre
  • Sweden
      • Goteborg, Sweden, SE 41685
        • Östra Sjukhuset
  • Switzerland
      • Geneva, Switzerland, CH-1211
        • Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Sion, Switzerland, CH 1951
        • Hopital du Valais - Hopital de Sion
      • Zurich, Switzerland, CH 8091
        • UniversitaetsSpital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced or metastatic colo-rectal cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Colo-rectal cancer
Tumour markers testing in patients with advanced or metastatic colo-rectal cancer
Genetic: Tumour markers testing
Tumour markers testing in patients advanced or metastatic colo-rectal cancer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tumour markers assessment
Time Frame: Within 1 week after patient registration
Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3
Within 1 week after patient registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EORTC-40CRC
  • 2012-003714-14 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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