Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients
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ClinicalTrials.gov Identifier: NCT01344330 |
Recruitment Status :
Completed
First Posted : April 29, 2011
Last Update Posted : December 19, 2020
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Sponsor:
Texas A&M University
Collaborators:
Oregon Health and Science University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roderick Dashwood, Texas A&M University
Tracking Information | |||||
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First Submitted Date | April 27, 2011 | ||||
First Posted Date | April 29, 2011 | ||||
Last Update Posted Date | December 19, 2020 | ||||
Actual Study Start Date | January 2012 | ||||
Actual Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites [ Time Frame: At colonoscopy (day 1) ] | ||||
Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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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 | Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients | ||||
Official Title | Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients | ||||
Brief Summary | This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description: Protein lysate and RNA obtained from de-identified normal colon biopsy specimens are stored at -80 degree centigrade.
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Sampling Method | Non-Probability Sample | ||||
Study Population | Patients scheduled for screening colonoscopy | ||||
Condition | Colon Cancer | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Screening colonoscopy patients
Men and women age 50 to 75 scheduled for screening colonoscopy
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Publications * | Not Provided | ||||
* 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 | Completed | ||||
Actual Enrollment |
108 | ||||
Original Estimated Enrollment |
150 | ||||
Actual Study Completion Date | December 2017 | ||||
Actual Primary Completion Date | December 2017 (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 | 50 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01344330 | ||||
Other Study ID Numbers | P01CA090890( U.S. NIH Grant/Contract ) P01CA090890 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Roderick Dashwood, Texas A&M University | ||||
Study Sponsor | Texas A&M University | ||||
Collaborators |
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Investigators |
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PRS Account | Texas A&M University | ||||
Verification Date | December 2020 |