Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Texas A&M University
Sponsor:
Collaborators:
Oregon Health and Science University
Information provided by (Responsible Party):
Texas A&M University
ClinicalTrials.gov Identifier:
NCT01344330
First received: April 27, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition
Colon Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Resource links provided by NLM:


Further study details as provided by Texas A&M University:

Primary Outcome Measures:
  • Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites [ Time Frame: At colonoscopy (day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs) [ Time Frame: at colonoscopy ] [ Designated as safety issue: No ]
  • Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue), [ Time Frame: at colonoscopy ] [ Designated as safety issue: No ]
  • Cruciferous vegetable intake correlated with HDAC activity (in PBMCs) [ Time Frame: at colonoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Screening colonoscopy patients
Men and women age 50 to 75 scheduled for screening colonoscopy

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled for screening colonoscopy

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344330

Contacts
Contact: To be named

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Matt French    503-494-7004    frenchm@ohsu.edu   
Contact: Carrie Farrar    503-494-4233    farrarc@ohsu.edu   
Principal Investigator: David Lieberman, MD         
Sponsors and Collaborators
Texas A&M University
Oregon Health and Science University
Investigators
Principal Investigator: Rod Dashwood, PhD Oregon State University
  More Information

No publications provided

Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT01344330     History of Changes
Other Study ID Numbers: P01 CA090890, P01CA090890
Study First Received: April 27, 2011
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas A&M University:
Colon cancer
Prevention
Cruciferous vegetables
Histone status

ClinicalTrials.gov processed this record on October 21, 2014