Colorectal CancerSPECTAcolorNCT01723969
Screening Platform for Clinical Trials in Advanced Colorectal Cancer
An observational study of Colorectal Cancer and Advanced Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Advanced Colorectal Cancer
- What is being tested?
- Tumour markers testing
- How many people
- 668 participants
- Where
- 27 sitesin 11 countries
- Study dates
- Sep 2013to 10 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced or metastatic colo-rectal cancer
Who may be able to join
- Colo-rectal cancer (advanced or metastatic)
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Who cannot join
- Absence of patient's consent
Trial locations and contacts
27 sites in 11 countries.
27 sites in 11 countries
Belgium5 sites
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels, 1000
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, 2650
U.Z. Leuven - Campus Gasthuisberg
Leuven, 3000
Germany5 sites
Universitaetsklinikum Carl Gustav Carus
Dresden, DE 01307
Universitaets-Krankenhaus Eppendorf
Hamburg, 20246
Universitaetsklinikum Leipzig
Leipzig, DE 04205
Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern
München, DE 81377
Kliniken Oldenburg
Oldenburg, DE 26133
Spain4 sites
Hospital General Vall D'Hebron
Barcelona, ES 08035
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, ES 08907
Hospital Universitario San Carlos
Madrid, ES 28040
Hospital Universitario 12 De Octubre
Madrid, ES 28041
Switzerland4 sites
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie
Geneva, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Hopital du Valais - Hopital de Sion
Sion, CH 1951
UniversitaetsSpital Zurich
Zurich, CH 8091
Italy2 sites
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro
Genova, 16132
Seconda Universita Degli Studi Di Napoli
Naples, 80138
Poland2 sites
The Great Poland Cancer Centre
Poznan, PL 61 866
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw, PL 02 781
Portugal1 site
I.P.O. Francisco Gentil - Centro De Lisboa
Lisbon, PT 1099-023
About this study
Official title: 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.
Read more
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
- Being tested
- Tumour markers testing
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour markers testingGenetic
Tumour markers testing in patients advanced or metastatic colo-rectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Colo-rectal cancer | Tumour markers testing in patients with advanced or metastatic colo-rectal cancer Receives: Genetic: Tumour markers testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour markers assessment
Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3
Measured: Within 1 week after patient registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startSep 2013
- Primary completion10 Apr 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gunnar Folprecht, MD, Study chair, Universitaetsklinikum Carl Gustav Carus, Dresden, DESabine Tejpar, MD, PhD, Study chair, U.Z. Leuven - Campus Gasthuisberg, Leuven, BEDaniela Aust, MD, Study chair, Universitaetsklinikum Carl Gustav Carus, Dresden, DE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723969
- Sponsor's protocol ID
- EORTC-40CRC
- Other IDs
- 2012-003714-14
- Acronym
- SPECTAcolor
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2012
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"
- ClinicalTrials.gov ID
- NCT01723969
- Acronym / sponsor ID
- SPECTAcolor / EORTC-40CRC
- Conditions
- Colorectal Cancer, Advanced Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Sep 2013 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colo-rectal cancer | – | Genetic: Tumour markers testingTumour markers testing in patients with advanced or metastatic colo-rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced or metastatic colo-rectal cancer
Key inclusion criteria (2 listed)
- Colo-rectal cancer (advanced or metastatic)
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Key exclusion criteria (1 listed)
- Absence of patient's consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumour markers testingTumour markers testing in patients advanced or metastatic colo-rectal cancer. | Genetic | Colo-rectal cancer |
Primary outcome
Tumour markers assessment
Time frame: Within 1 week after patient registration
Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Folprecht, MD study chair
Universitaetsklinikum Carl Gustav Carus, Dresden, DE
Sabine Tejpar, MD, PhD study chair
U.Z. Leuven - Campus Gasthuisberg, Leuven, BE
Daniela Aust, MD study chair
Universitaetsklinikum Carl Gustav Carus, Dresden, DE
27 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Advanced Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 27 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Belgium, Germany, Spain, Switzerland, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour markers assessment (time frame: Within 1 week after patient registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.