Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

NCT ID: NCT01344330

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Colon Cancer

Keywords

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Colon cancer Prevention Cruciferous vegetables Histone status

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Screening colonoscopy patients

Men and women age 50 to 75 scheduled for screening colonoscopy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Roderick Dashwood

Professor, Texas A&M HSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rod Dashwood, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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P01CA090890

Identifier Type: NIH

Identifier Source: secondary_id

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P01CA090890

Identifier Type: NIH

Identifier Source: org_study_id

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