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Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project (IMPACT)
This study is currently recruiting participants.
Verified June 2016 by National Cancer Centre, Singapore
Sponsor:
National Cancer Centre, Singapore
Information provided by (Responsible Party):
National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT02806388
First received: June 16, 2016
Last updated: June 17, 2016
Last verified: June 2016
| Tracking Information | |||||
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| First Received Date ICMJE | June 16, 2016 | ||||
| Last Updated Date | June 17, 2016 | ||||
| Start Date ICMJE | October 2011 | ||||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The molecular and clinical epidemiology for cancer patients being considered for novel therapeutics [ Time Frame: 5 years ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project | ||||
| Official Title ICMJE | Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project | ||||
| Brief Summary | This study aims to screen tumor molecular profile for better selection of anticancer treatment, in particular, allocation to clinical trials if available. | ||||
| Detailed Description | Molecular profiling will be performed on archival tumor tissue or freshly collected tumor tissue from re-biopsy. Blood and/or saliva may be collected to study the genetic makeup and also to compare the tumor molecular profile. Personalized therapy will be given based on molecular profile. | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Remaining tumor and/or blood and/or saliva |
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| Sampling Method | Probability Sample | ||||
| Study Population | Any advanced cancer patient who would benefit from molecular profiling and is a potential clinical trial candidate as identified by treating physician. | ||||
| Condition ICMJE | Solid Tumor | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Groups/Cohorts | tumor tissue for molecular profiling | ||||
| 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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1500 | ||||
| Estimated Completion Date | December 2018 | ||||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: |
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| Sex/Gender |
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| Ages | 21 Years and older (Adult, Senior) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Singapore | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT02806388 | ||||
| Other Study ID Numbers ICMJE | ECRU-IMPACT | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | National Cancer Centre, Singapore | ||||
| Study Sponsor ICMJE | National Cancer Centre, Singapore | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | National Cancer Centre, Singapore | ||||
| Verification Date | June 2016 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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