Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Colon Cancer Clinical Trial

Official title:

Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344330
• Other study ID #: P01CA090890
• Secondary ID: P01CA090890
• Status: Completed
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: December 2020
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Texas A&M University	National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites		At colonoscopy (day 1)
Secondary	Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs)		at colonoscopy
Secondary	Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue),		at colonoscopy
Secondary	Cruciferous vegetable intake correlated with HDAC activity (in PBMCs)		at colonoscopy