Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

NCT01344330 | Completed DMC

• 1 other identifier: P01CA090890
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

Colon cancer; Prevention; Cruciferous vegetables; Histone status

Outcome Measures

Primary Outcomes (1)

• Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites

  At colonoscopy (day 1)

Secondary Outcomes (3)

• Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs)

  at colonoscopy

• Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue),

  at colonoscopy

• Cruciferous vegetable intake correlated with HDAC activity (in PBMCs)

  at colonoscopy

Study Arms (1)

Screening colonoscopy patients

Men and women age 50 to 75 scheduled for screening colonoscopy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for screening colonoscopy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas A&M University: lead
• Oregon Health and Science University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Protein lysate and RNA obtained from de-identified normal colon biopsy specimens are stored at -80 degree centigrade.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Rod Dashwood, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Texas A&M HSC

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 29, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)