Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer
This study is currently recruiting participants.
Verified December 2012 by University of Arkansas
Sponsor:
University of Arkansas
Collaborator:
Genomic Health
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01479894
First received: November 17, 2011
Last updated: December 11, 2012
Last verified: December 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 17, 2011 | ||||||||
| Last Updated Date | December 11, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Compare the prognosis of colon cancer patients compared to gene expression. [ Time Frame: 1 year ] [ Designated as safety issue: No ] Compare the values of the Recurrence Score and expression levels of gene groups and individual genes between African Americans and Caucasians with Stage II colon cancer |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01479894 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be analyzed as well. Three institutions will contribute patients to this study with a total patient number goal of approximately 200 with approximately 100 being AA and approximately 100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched for every African American enrolled. |
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| Detailed Description | Not Provided | ||||||||
| 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: The Oncotype DX Colon Cancer Assay will be utilized to define the gene expression profile of the tumor tissue. |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. As such, all eligible patients must have a stored tumor specimen which can be accessed for analysis. |
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| Condition ICMJE | Colon Cancer | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Sample Collection
This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. As such, all eligible patients must have a stored tumor specimen which can be accessed for analysis. |
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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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01479894 | ||||||||
| Other Study ID Numbers ICMJE | 133972 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Arkansas | ||||||||
| Study Sponsor ICMJE | University of Arkansas | ||||||||
| Collaborators ICMJE | Genomic Health | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of Arkansas | ||||||||
| Verification Date | December 2012 | ||||||||
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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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