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Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Texas A&M University logo

Texas A&M University

Status

Completed

Conditions

Colon Cancer

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01344330
P01CA090890 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

108 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

108 participants in 1 patient group

Screening colonoscopy patients
Description:
Men and women age 50 to 75 scheduled for screening colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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