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Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

This study is currently recruiting participants.
Verified May 2016 by Texas A&M University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344330
First Posted: April 29, 2011
Last Update Posted: May 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Oregon Health and Science University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Texas A&M University
  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) ]

Secondary Outcome Measures:
  • Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs) [ Time Frame: at colonoscopy ]
  • Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue), [ Time Frame: at colonoscopy ]
  • Cruciferous vegetable intake correlated with HDAC activity (in PBMCs) [ Time Frame: at colonoscopy ]

Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344330


Contacts
Contact: To be named

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Matthew 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rod Dashwood, PhD Oregon State University
  More Information

Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT01344330     History of Changes
Other Study ID Numbers: P01CA090890 ( U.S. NIH Grant/Contract )
First Submitted: April 27, 2011
First Posted: April 29, 2011
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Group information (High versus Low Cruciferous Vegetable Intake) will be made available. No IPD will be made available.

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases