Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

• ClinicalTrials.gov Identifier: NCT01344330
• Recruitment Status: Unknown
• First Posted: April 29, 2011
• Last Update Posted: May 10, 2016
• Sponsor: Texas A&M University
• Collaborators: Oregon Health and Science University; National Cancer Institute (NCI)
• Information provided by (Responsible Party): Texas A&M University

Tracking Information

• First Submitted Date: April 27, 2011
• First Posted Date: April 29, 2011
• Last Update Posted Date: May 10, 2016
• Study Start Date: January 2012
• Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 17, 2013): Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites [ Time Frame: At colonoscopy (day 1) ]

Original Primary Outcome Measures (submitted: April 28, 2011)

• SFN and I3C urinary metabolites [ Time Frame: At time of colonoscopy (day 1) ]
• Cruciferous vegetable intake [ Time Frame: At time of colonoscopy (day 1) ]
• HDAC activity (in PBMCs) [ Time Frame: At time of Colonoscopy (day 1) ]
• acetylated histone expression (PBMCs, colon tissue) [ Time Frame: At time of Colonoscopy (day 1) ]
• p21 expression (qRT-PCR, ChIP in PBMCs) [ Time Frame: At time of Colonoscopy (day 1) ]

Current Secondary Outcome Measures (submitted: May 17, 2013)

• Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs) [ Time Frame: at colonoscopy ]
• Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue), [ Time Frame: at colonoscopy ]
• Cruciferous vegetable intake correlated with HDAC activity (in PBMCs) [ Time Frame: at colonoscopy ]

• 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: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 28, 2011): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2017
• Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• scheduled for screening colonoscopy
• off NSAID or aspirin therapy in accordance with OHSU endoscopy clinic guidelines
• INR 0.90-1.20
• hemoglobin ≥ 13.5 (men) or 12.0 (women)
• platelets ≥100,000/μL
• Chem screen results within normal limits
• negative (serum or urine) pregnancy test done ≤7 days prior to colonoscopy for women of childbearing potential only
• ASA performance status <2

Exclusion criteria:

• history of colon cancer or adenomatous polyps
• current smoker
• medical history of chronic obstructive pulmonary disease
• current oral steroid therapy
• current therapy with valproate or other pharmacological drugs associated with HDAC inhibition
• use of oral antibiotics within 3 months prior to entry into study
• significant active medical illness which in the opinion of the investigator would preclude collection/interpretation of colon tissue
• diagnosis of hemophilia, van Willebrand's disease or other bleeding disorder
• use of warfarin or other blood thinning agents
• inflammatory bowel disease.

Sex/Gender

• Sexes Eligible for Study: All

• 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

Administrative Information

• NCT Number: NCT01344330
• Other Study ID Numbers: P01CA090890( U.S. NIH Grant/Contract ); P01CA090890 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Group information (High versus Low Cruciferous Vegetable Intake) will be made available. No IPD will be made available.

• Responsible Party: Texas A&M University
• Study Sponsor: Texas A&M University

Collaborators

• Oregon Health and Science University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Rod Dashwood, PhD; Oregon State University

• PRS Account: Texas A&M University
• Verification Date: May 2016