Clinical trial NCT02289053: Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
Official title: Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colon Polyps
Adenomatous Polyp of Colon
Keywords: Colorectal Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-11-13
Enrollment: 1623
Sex: ALL
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are recruited from the endoscopy units of the participating study sites prior to their colonoscopy procedure.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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);
* 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.

Primary outcomes:
measure: Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer
timeFrame: Data analysis will begin September 2014 for a duration of three months.
Secondary outcomes:
measure: Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer
timeFrame: Data analysis will begin September 2014 for a duration of three months.
measure: Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps
timeFrame: Data analysis will begin September 2014 for a duration of three months.
Other outcomes:
measure: Risk factors associated with the presence of advanced adenomas
timeFrame: Data analysis will begin September 2014 for a duration of three months.
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: Ann Arbor VA Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastro
state: Michigan
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: University of Michigan
name: Philip Schoenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: