Colon Cancer
Conditions
Brief summary
The investigators will recruit DoD beneficiaries 18 years or older, that have been referred for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to determine if there is an association between the level obtained and findings on colonoscopy, or previous findings (if repeating).
Detailed description
DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate: Screening Visit: * Obtain signed Informed Consent Document and HIPAA Authorization (research-driven). * Record: Date of birth, age, gender, race, ethnicity, current email address, height (in inches), weight (in pounds), waist circumference (in inches) measurement, blood pressure, and whether subject is taking or has taken any vitamin D supplement or derivative, and if so, note the dosage, frequency, and duration of therapy. * Subjects will be told to fast for at least 10 hours prior to Visit 1 Visit 1 (within two weeks of their screening colonoscopy): -Subjects will have the following research-driven blood test drawn which include: Serum 25-OH vitamin D via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)
Interventions
OTHERScreening Colonoscopy
we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance
Sponsors
Mike O'Callaghan Military Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion: * DoD beneficiaries 18 years or older * Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks Exclusion: * Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer * Military trainees * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Vitamin D | 2 weeks | Vitamin D blood levels will be obtained at the time of procedure. |
| Adenomatous Polyps | 2 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Screening Colonoscopy Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks
Screening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance | 298 |
| Total | 298 |
Baseline characteristics
| Characteristic | Screening Colonoscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 298 Participants |
| Sex: Female, Male Female | 134 Participants |
| Sex: Female, Male Male | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 298 |
| other Total, other adverse events | 0 / 298 |
| serious Total, serious adverse events | 0 / 298 |
Outcome results
Primary
Adenomatous Polyps
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening Colonoscopy | Adenomatous Polyps | found to have adenomatous polyps | 104 Participants |
| Screening Colonoscopy | Adenomatous Polyps | did not have adenomatous polyps | 124 Participants |
Primary
Serum Vitamin D
Vitamin D blood levels will be obtained at the time of procedure.
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening Colonoscopy | Serum Vitamin D | vitamin D normal (>30ng/ml) | 73 Participants |
| Screening Colonoscopy | Serum Vitamin D | vitamin D insufficiency (<30ng/ml) | 155 Participants |