Screening Platform for Clinical Trials in Advanced Colorectal Cancer (SPECTAcolor)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01723969 |
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Recruitment Status :
Active, not recruiting
First Posted : November 8, 2012
Last Update Posted : June 21, 2019
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Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator:
Alliance Boots
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
| Tracking Information | ||||||||||
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| First Submitted Date | November 5, 2012 | |||||||||
| First Posted Date | November 8, 2012 | |||||||||
| Last Update Posted Date | June 21, 2019 | |||||||||
| Study Start Date | September 2013 | |||||||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Tumour markers assessment [ Time Frame: Within 1 week after patient registration ] Five basic tumour markers will be tested: Kras, nras, braf, MSI and PKI3
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Screening Platform for Clinical Trials in Advanced Colorectal Cancer | |||||||||
| Official Title | Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor" | |||||||||
| 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. |
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| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: FFPE blocks of tumour tissue
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| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Patients with advanced or metastatic colo-rectal cancer | |||||||||
| Condition |
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| Intervention | Genetic: Tumour markers testing
Tumour markers testing in patients advanced or metastatic colo-rectal cancer.
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| Study Groups/Cohorts | Colo-rectal cancer
Tumour markers testing in patients with advanced or metastatic colo-rectal cancer
Intervention: Genetic: Tumour markers testing
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Active, not recruiting | |||||||||
| Actual Enrollment |
668 | |||||||||
| Original Estimated Enrollment |
2600 | |||||||||
| Estimated Study Completion Date | February 2020 | |||||||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Belgium, Cyprus, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden, Switzerland | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01723969 | |||||||||
| Other Study ID Numbers | EORTC-40CRC 2012-003714-14 ( EudraCT Number ) |
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| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||
| Study Sponsor | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||
| Collaborators | Alliance Boots | |||||||||
| Investigators |
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| PRS Account | European Organisation for Research and Treatment of Cancer - EORTC | |||||||||
| Verification Date | June 2019 | |||||||||