Colorectal CancerNCT00087360
Genetic and Environmental Risk Assessment for Colorectal Cancer in Healthy Participants
A study testing counseling intervention, physiologic testing and evaluation of cancer risk factors in people with Colorectal Cancer, run by Fox Chase Cancer Center at 4 sites in United States.
Trial summary
RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- counseling intervention, physiologic testing and evaluation of cancer risk factors
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Nov 2003to May 2007
- Phase
- Interventional
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Healthy participants
- Eligible for colorectal cancer screening
- No personal or family history of colorectal cancer
- No more than 1 first-degree relative who has had colorectal cancer
- Part 1:
- Has not undergone regular screening for colorectal cancer
- Part 2:
- Not currently undergoing regular colon cancer testing, including any of the following:
- Fecal occult blood testing within the past year
- Flexible sigmoidoscopy or colonoscopy within the past 5 years
PATIENT CHARACTERISTICS:
Age
- 50 to 74
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No inflammatory bowel disease (part 1 only)
- No concurrent health issues that would preclude study participation (part 1 only)
- No history of cancer except basal cell or squamous cell skin cancer (part 2 only)
- Able to speak and read English (part 2 only)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-0165
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Providing Genetic And Environmental Cancer Risk Assessment In Primary Care
RATIONALE: Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening.
PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer.
Read the detailed description
OBJECTIVES:
Part 1
- Determine the willingness of healthy participants to enroll in a genetic and environmental risk assessment for colorectal cancer.
- Determine the impact of decision counseling on knowledge and attitudes about genetic and environmental risk assessment (GERA) and colorectal cancer screening in these participants.
- Determine participants' understanding of GERA.
- Determine participants' response to GERA results.
Part 2
- Determine awareness of, and interest in, diet and genetic assessment for colorectal cancer among healthy participants at average risk for colorectal cancer who have not undergone regular colon cancer screening.
- Determine participants' level of knowledge of this assessment.
- Determine participants' rate of acceptance into this study.
OUTLINE: This is a 2-part pilot study.
- Part 1: Participants complete a baseline questionnaire on attitudes, beliefs, and knowledge about colorectal cancer (CRC), CRC screening, and diet and genetic testing for colorectal cancer risk. Two-four weeks later, participants are educated about CRC screening options and undergo genetic and environmental risk assessment (GERA) decision counseling about the methylene tetrahydrofolate reductase (MTHFR) gene and dietary folate intake. Participants who decide to undergo GERA undergo blood testing for MTHFR polymorphisms and folate levels. Participants whose blood tests indicate low folate levels are further counseled about dietary folate intake.
- Part 2: Participants complete a questionnaire on attitudes, beliefs, and knowledge about CRC, CRC screening, and diet and genetic testing for colorectal cancer risk.
Participants in part 1 are followed at 1 week, 1 month, and then at 6 months.
PROJECTED ACCRUAL: A total of 110 participants (60 for part 1 and 50 for part 2) will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- counseling intervention, physiologic testing, evaluation of cancer risk factors
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
physiologic testingOther
evaluation of cancer risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer (CRC) screening rates by chart review at 4 months
Secondary outcomes (2)
Knowledge regarding CRC risk by questionnaires at 4 and 12 months
CRC risk perception by questionnaires at 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startNov 2003
- Primary completionMay 2007
- Study completionMay 2007
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.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Weinberg, MD, MSC, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087360
- Sponsor's protocol ID
- FCCC-03030
- Other IDs
- CDR0000374972
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2004
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Weinberg DS, Myers RE, Keenan E, Ruth K, Sifri R, Ziring B, Ross E, Manne SL. Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial. Ann Intern Med. 2014 Oct 21;161(8):537-45. doi: 10.7326/M14-0765.
PubMed 25329201
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Genetic And Environmental Cancer Risk Assessment In Primary Care
- ClinicalTrials.gov ID
- NCT00087360
- Acronym / sponsor ID
- FCCC-03030
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 Jul 2004 (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: Evaluating the knowledge and attitudes of healthy participants toward a new diet and gene test for colorectal cancer risk may help doctors improve acceptance of colorectal cancer screening.
PURPOSE: This clinical trial is studying the knowledge and attitudes of healthy participants toward genetic and environmental risk assessment for colorectal cancer.
Detailed description
OBJECTIVES:
Part 1
- Determine the willingness of healthy participants to enroll in a genetic and environmental risk assessment for colorectal cancer.
- Determine the impact of decision counseling on knowledge and attitudes about genetic and environmental risk assessment (GERA) and colorectal cancer screening in these participants.
- Determine participants' understanding of GERA.
- Determine participants' response to GERA results.
Part 2
- Determine awareness of, and interest in, diet and genetic assessment for colorectal cancer among healthy participants at average risk for colorectal cancer who have not undergone regular colon cancer screening.
- Determine participants' level of knowledge of this assessment.
- Determine participants' rate of acceptance into this study.
OUTLINE: This is a 2-part pilot study.
- Part 1: Participants complete a baseline questionnaire on attitudes, beliefs, and knowledge about colorectal cancer (CRC), CRC screening, and diet and genetic testing for colorectal cancer risk. Two-four weeks later, participants are educated about CRC screening options and undergo genetic and environmental risk assessment (GERA) decision counseling about the methylene tetrahydrofolate reductase (MTHFR) gene and dietary folate intake. Participants who decide to undergo GERA undergo blood testing for MTHFR polymorphisms and folate levels. Participants whose blood tests indicate low folate levels are further counseled about dietary folate intake.
- Part 2: Participants complete a questionnaire on attitudes, beliefs, and knowledge about CRC, CRC screening, and diet and genetic testing for colorectal cancer risk.
Participants in part 1 are followed at 1 week, 1 month, and then at 6 months.
PROJECTED ACCRUAL: A total of 110 participants (60 for part 1 and 50 for part 2) will be accrued for this study.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| counseling intervention | Other | – |
| physiologic testing | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Colorectal cancer (CRC) screening rates by chart review at 4 months
2 secondary outcomes
Knowledge regarding CRC risk by questionnaires at 4 and 12 months
CRC risk perception by questionnaires at 4 and 12 months
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 11 Jul 2013.
- Derived from this study: PubMed 25329201Weinberg DS, Myers RE, Keenan E, Ruth K, Sifri R, Ziring B, Ross E, Manne SL. Genetic and environmental risk assessment and colorectal cancer screening in an average-risk population: a randomized trial. Ann Intern Med. 2014 Oct 21;161(8):537-45. doi: 10.7326/M14-0765.
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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.
David Weinberg, MD, MSC study chair
Fox Chase Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, physiologic testing and evaluation of cancer risk factors in people with Colorectal Cancer, run by Fox Chase Cancer Center 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 11 Jul 2013. 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?
Colorectal cancer (CRC) screening rates by chart review at 4 months. 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 NCT00087360, 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 11 Jul 2013.