NCT02269332

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

October 14, 2014

Results QC Date

June 22, 2020

Last Update Submit

January 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Serum Vitamin D

    Vitamin D blood levels will be obtained at the time of procedure.

    2 weeks

  • Adenomatous Polyps

    2 weeks

Study Arms (1)

Screening Colonoscopy

Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks

Other: Screening Colonoscopy

Interventions

we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance

Screening Colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • DoD beneficiaries 18 years or older
  • Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks

You may not qualify if:

  • Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer
  • Military trainees
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Las Vegas, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Senior Research Associate/Research Manager
Organization
Mike O'Callaghan Military Medical Center

Study Officials

  • Carl Bryce, MD

    Mike O'Callaghan Federal Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 21, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 22, 2024

Results First Posted

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations