Colorectal CancerNCT00625066
Biological, Genetic, and Lifestyle Risk Factors for Developing Colorectal Adenomas or Polyps in Participants Undergoing Colonoscopy
An observational study of Colorectal Cancer and Precancerous Condition, run by Vanderbilt University at 4 sites in United States.
Trial summary
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Precancerous Condition
- What is being tested?
- biologic sample preservation procedure, cytology specimen collection procedure and medical chart review
- Type of treatment
- Surgery or procedure
- How many people
- 8,108 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2003to 30 Nov 2025
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants who are planning to undergo colonoscopy
DISEASE CHARACTERISTICS:
- Scheduled to undergo colonoscopy at the Vanderbilt University Medical Center or the Tennessee Valley Veterans Administration Medical Center
- No prior genetic colorectal cancer syndromes or colorectal adenoma
PATIENT CHARACTERISTICS:
- Must have a permanent residence and a telephone number
- Able to speak and understand English
- No prior inflammatory bowel disease
- No prior cancer other than nonmelanoma skin cancer
- Not a current resident in a correctional facility
- No other rare exclusion that would prevent the collection of study data (e.g., extensive memory loss for past exposures), impair ability to provide informed consent, or make the participant an atypical colonoscopy patient (e.g., colonoscopy for organ transplant evaluation)
- No prior extensive knowledge or contact with the investigation/protocol/hypotheses (the study collaborator or reviewer)
PRIOR CONCURRENT THERAPY:
- No prior partial or complete colon resection
- No concurrent participation in a clinical trial involving the prevention of colon polyps
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Tennessee Colorectal Polyp Study
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors.
PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
Read the detailed description
OBJECTIVES:
- To recruit 7,000 participants who are planning to undergo colonoscopy.
- To collect questionnaires and medical records from these participants.
- To collect biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps from these participants.
- To evaluate risk factors and other differences between participants found to have polyps and those who do not have polyps.
OUTLINE: Participants undergo screening colonoscopy and removal of any polyps.
Within 1 month of colonoscopy, participants undergo a 30-minute telephone interview and/or complete a mail survey to provide information on lifestyle and medical history that may be related to colorectal polyp risk. Participants who undergo removal of polyps during their colonoscopy also complete a 20-minute survey at their 3-year follow-up colonoscopy. Participants' medical records may also be reviewed.
Blood samples are collected at the time of colonoscopy. Some participants may also provide blood samples 1-2 weeks prior to colonoscopy. Tissue from the bisected portions of colorectal polyps > 5 mm in size that are removed during colonoscopy is also obtained. Some participants may also undergo normal colorectal tissue sample and saliva sample collection at the time of colonoscopy and urine sample collection 2 days prior to, during, and/or 8 weeks after colonoscopy.
Tissue samples may be stored for future genetic studies to evaluate genetic factors that may cause or be related to colon polyps or colorectal cancer.
- Conditions
- Colorectal Cancer, Precancerous Condition
- Being tested
- biologic sample preservation procedure, cytology specimen collection procedure, medical chart review, questionnaire administration, survey administration
- Keywords
- precancerous condition, colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Precancerous Conditions, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
cytology specimen collection procedureOther
medical chart reviewOther
questionnaire administrationOther
survey administrationOther
biopsyProcedure or surgery
evaluation of cancer risk factorsProcedure or surgery
screening colonoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of 7,000 participants who are planning to undergo colonoscopy
Collection of questionnaires and medical records
Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps
Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study start1 Jan 2003
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Wei Zheng, Vanderbilt University
- Investigators
- Wei Zheng, MD, PhD, MPH, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625066
- Sponsor's protocol ID
- CDR0000583154
- Other IDs
- P30CA068485, VU-VICC-GI-0294, VU-VICC-020603, VU-VICC-020531
- Status last verified
- Dec 2025
- First submitted
- 27 Feb 2008
- Last updated
- 17 Dec 2025
- Results posted
- No
Publications
Murff HJ, Shrubsole MJ, Cai Q, Smalley WE, Dai Q, Milne GL, Ness RM, Zheng W. Dietary intake of PUFAs and colorectal polyp risk. Am J Clin Nutr. 2012 Mar;95(3):703-12. doi: 10.3945/ajcn.111.024000. Epub 2012 Jan 25.
PubMed 22277551
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tennessee Colorectal Polyp Study
- ClinicalTrials.gov ID
- NCT00625066
- Acronym / sponsor ID
- CDR0000583154
- Conditions
- Colorectal Cancer, Precancerous Condition
- Keywords
- precancerous condition, colon cancer, rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,108 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 28 Feb 2008 (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.
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors.
PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
Detailed description
OBJECTIVES:
- To recruit 7,000 participants who are planning to undergo colonoscopy.
- To collect questionnaires and medical records from these participants.
- To collect biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps from these participants.
- To evaluate risk factors and other differences between participants found to have polyps and those who do not have polyps.
OUTLINE: Participants undergo screening colonoscopy and removal of any polyps.
Within 1 month of colonoscopy, participants undergo a 30-minute telephone interview and/or complete a mail survey to provide information on lifestyle and medical history that may be related to colorectal polyp risk. Participants who undergo removal of polyps during their colonoscopy also complete a 20-minute survey at their 3-year follow-up colonoscopy. Participants' medical records may also be reviewed.
Blood samples are collected at the time of colonoscopy. Some participants may also provide blood samples 1-2 weeks prior to colonoscopy. Tissue from the bisected portions of colorectal polyps > 5 mm in size that are removed during colonoscopy is also obtained. Some participants may also undergo normal colorectal tissue sample and saliva sample collection at the time of colonoscopy and urine sample collection 2 days prior to, during, and/or 8 weeks after colonoscopy.
Tissue samples may be stored for future genetic studies to evaluate genetic factors that may cause or be related to colon polyps or colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants who are planning to undergo colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologic sample preservation procedure | Other | – |
| cytology specimen collection procedure | Other | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| survey administration | Other | – |
| biopsy | Procedure or surgery | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
| screening colonoscopy | Procedure or surgery | – |
Primary outcome
Recruitment of 7,000 participants who are planning to undergo colonoscopy
Collection of questionnaires and medical records
Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps
Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps
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 17 Dec 2025.
- Derived from this study: PubMed 22277551Murff HJ, Shrubsole MJ, Cai Q, Smalley WE, Dai Q, Milne GL, Ness RM, Zheng W. Dietary intake of PUFAs and colorectal polyp risk. Am J Clin Nutr. 2012 Mar;95(3):703-12. doi: 10.3945/ajcn.111.024000. Epub 2012 Jan 25.
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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.
Wei Zheng, MD, PhD, MPH study chair
Vanderbilt-Ingram Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Precancerous Condition, run by Vanderbilt University at 4 sites 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?
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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Recruitment of 7,000 participants who are planning to undergo colonoscopy. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00625066, which also lists 1 linked publication.
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 17 Dec 2025.