Colon CancerNCT01344330
Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients
An observational study of Colon Cancer, run by Texas A&M University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for screening colonoscopy
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97201
About this study
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
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Screening colonoscopy patients | Men and women age 50 to 75 scheduled for screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites
Measured: At colonoscopy (day 1)
Secondary outcomes (3)
Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs)
Measured: at colonoscopy
Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue),
Measured: at colonoscopy
Cruciferous vegetable intake correlated with HDAC activity (in PBMCs)
Measured: at colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roderick Dashwood, Texas A&M University
- Investigators
- Rod Dashwood, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344330
- Sponsor's protocol ID
- P01CA090890
- Other IDs
- P01CA090890
- Status last verified
- Dec 2020
- First submitted
- 27 Apr 2011
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Group information (High versus Low Cruciferous Vegetable Intake) will be made available. No IPD will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients
- ClinicalTrials.gov ID
- NCT01344330
- Acronym / sponsor ID
- P01CA090890
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, Prevention, Cruciferous vegetables, Histone status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, National Cancer Institute (NCI)
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening colonoscopy patients | – | –Men and women age 50 to 75 scheduled for screening colonoscopy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for screening colonoscopy
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites
Time frame: At colonoscopy (day 1)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No. Group information (High versus Low Cruciferous Vegetable Intake) will be made available. No IPD will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rod Dashwood, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites (time frame: At colonoscopy (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.