Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention

CompletedOBSERVATIONAL
Enrollment

264

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

February 29, 2016

Study Completion Date

August 31, 2016

Conditions
Colorectal Adenomatous Polyps
Interventions
PROCEDURE

Rectal biopsy during colonoscopy

Biopsies of rectal tissue will be obtained during the 3 or 5 year follow-up colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.

PROCEDURE

Rectal biopsy at randomization

Biopsies of rectal tissue will be obtained at the time of randomization. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.

PROCEDURE

Rectal biopsy at 1 year

Biopsies of rectal tissue will be obtained at the time of the one year follow-up visit. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.

PROCEDURE

Rectal biopsy prior to colonoscopy

Biopsies of rectal tissue will be obtained 7-21 days prior to the 3 or 5 year colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.

PROCEDURE

Biopsies during colonoscopy

Biopsies of the rectum, sigmoid colon and ascending colon will be obtained during the 3-5 year follow-up colonoscopy. The colonoscopy involves insertion of a flexible tube through the anus, which is then advanced the full length of the colon. Biopsies (tiny pinches of tissue less than 1/16 of an inch thick) will be taken as the colonoscopy tube is being removed. In total, 12-16 biopsies will be taken from the rectum (or lower colon about 3 - 4 inches up), sigmoid colon and ascending colon.

Trial Locations (9)

27599

University of North Carolina, Chapel Hill

29039

University of South Carolina, West Columbia

30322

Emory University, Atlanta

44195

Cleveland Clinic Foundation, Cleveland

52242

University of Iowa Hospitals & Clinic, Iowa City

55455

University of Minnesota, Minneapolis

80220

University of Colorado Health Sciences Center, Denver

90089

USC/Norris Comprehensice Cancer Center, Los Angeles

03756

Dartmouth-Hitchcock Medical Center, Lebanon

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Emory University

OTHER

NCT00399607 - Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention | Biotech Hunter | Biotech Hunter