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Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

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ClinicalTrials.gov Identifier: NCT01344330
Recruitment Status : Unknown
Verified May 2016 by Texas A&M University.
Recruitment status was:  Recruiting
First Posted : April 29, 2011
Last Update Posted : May 10, 2016
Sponsor:
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) ]
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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