Colorectal CancerNCT02289053
Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
An observational study of Colorectal Cancer and Colon Polyps, run by University of Michigan at 6 sites in United States.
Trial summary
Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal… Read more about this study
- Who is it for?
- Ages 40 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colon Polyps, Adenomatous Polyp of Colon
- How many people
- 1,623 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Apr 2006to 30 Jun 2014
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants are recruited from the endoscopy units of the participating study sites prior to their colonoscopy procedure.
Who may be able to join
- 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of CRC in a first degree relative;
- 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of polyps in a first degree relative;
- 40-49 year old men and women without a family history of CRC or polyps in a first degree relative who are referred for colonoscopy to evaluate scant hematochezia characterized as red blood on toilet tissue after wiping or small droplets of blood on stool or in toilet water after evacuating stool, abdominal discomfort or altered bowel habits characterized as constipation or diarrhea.
Who cannot join
- Personal history of iron deficiency anemia within six months of referral;
- Personal history of iron deficiency without anemia within six months of referral;
- Personal history of (+) FOBT within one year of referral;
- Personal history of previous colonoscopy or barium enema within the past 10 years;
- Personal history of previous flexible sigmoidoscopy in the past 5 years;
- Personal history of adenoma, colorectal cancer, inflammatory bowel disease, HNPCC, or familial adenomatous polyposis (FAP);
Show all 9Show fewer
- Unintentional weight loss > 10 lbs within the previous six months;
- Individuals with family history of CRC AND scant hematochezia;
- Inability to speak and read English.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ann Arbor VA Healthcare System
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
John D. Dingell VA Medical Center
Detroit, Michigan, 48201
Durham VA Medical Center
Durham, North Carolina, 27705
Huron Gastro
Ypsilanti, Michigan, 48197
About this study
Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.
- Conditions
- Colorectal Cancer, Colon Polyps, Adenomatous Polyp of Colon
- Keywords
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
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 |
|---|---|---|
| Positive Family History | Eligible participants with a family history of colorectal cancer or polyps will be grouped into the "subjects" group. | |
| Average Risk Patients | Eligible participants without a family history of colorectal cancer or polyps will be grouped into the "control" group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer
The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.
Measured: Data analysis will begin September 2014 for a duration of three months.
Secondary outcomes (2)
Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer
The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.
Measured: Data analysis will begin September 2014 for a duration of three months.
Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps
The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.
Measured: Data analysis will begin September 2014 for a duration of three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study start1 Apr 2006
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Schoenfeld, University of Michigan
- Investigators
- Philip Schoenfeld, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289053
- Sponsor's protocol ID
- K24-DK
- Other IDs
- 1K24DK084208
- Status last verified
- May 2017
- First submitted
- 26 Feb 2014
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
- ClinicalTrials.gov ID
- NCT02289053
- Acronym / sponsor ID
- K24-DK
- Conditions
- Colorectal Cancer, Colon Polyps, Adenomatous Polyp of Colon
- Keywords
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,623 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 13 Nov 2014 (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.
Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Family History | – | –Eligible participants with a family history of colorectal cancer or polyps will be grouped into the "subjects" group. |
| Average Risk Patients | – | –Eligible participants without a family history of colorectal cancer or polyps will be grouped into the "control" group. |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants are recruited from the endoscopy units of the participating study sites prior to their colonoscopy procedure.
Key inclusion criteria (3 listed)
- 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of CRC in a first degree relative;
- 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of polyps in a first degree relative;
- 40-49 year old men and women without a family history of CRC or polyps in a first degree relative who are referred for colonoscopy to evaluate scant hematochezia characterized as red blood on toilet tissue after wiping or small droplets of blood on stool or in toilet water after evacuating stool, abdominal discomfort or altered bowel habits characterized as constipation or diarrhea.
Key exclusion criteria (9 listed)
- Personal history of iron deficiency anemia within six months of referral;
- Personal history of iron deficiency without anemia within six months of referral;
- Personal history of (+) FOBT within one year of referral;
- Personal history of previous colonoscopy or barium enema within the past 10 years;
- Personal history of previous flexible sigmoidoscopy in the past 5 years;
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
Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer
Time frame: Data analysis will begin September 2014 for a duration of three months.
The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.
2 secondary outcomes
Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer
Time frame: Data analysis will begin September 2014 for a duration of three months.
Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps
Time frame: Data analysis will begin September 2014 for a duration of three 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 15 May 2017.
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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.
Philip Schoenfeld, MD principal investigator
University of Michigan
6 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 Colon Polyps, run by University of Michigan at 6 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?
The sponsor lists 3 inclusion and 9 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer (time frame: Data analysis will begin September 2014 for a duration of three months.). 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 15 May 2017.