Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399607
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2006-11-13
Brief Title:
CalciumVitamin D Biomarkers Colon Polyp Prevention
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
CalciumVitamin D Biomarkers Colon Polyp Prevention
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPS4B
Brief Summary:
The study team has developed a set of biomarkers of risk for colon cancer this study tests 1 whether or not calcium andor vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer ie have already undergone the removal of colon growths called adenomatous polyps which are known to be precursors to developing colon cancer and 2 whether effects on the biomarkers predict who will get new colon polyps or not
Detailed Description:
This study is an add-on study adjunct study to a clinical trial that is already being conducted the parent study Study participants will be composed of persons who are already participating in the parent study Vitamin DCalcium Polyp Prevention Study In the parent study a total of 1964 people nationally are being randomly assigned to four different treatment groups 1 calcium supplements 600 mg twice a day 2 vitamin D supplements 500 IU twice a day 3 both the calcium and vitamin D supplements twice a day and 4 placebo tablets twice a day The treatment period lasts three to five years at the end of which study participants undergo a follow-up colonoscopy to look for new polyps The parent study began about a year prior to the start of this adjunct study thus there are already some patients in the trial who are receiving their study treatments ie have been randomized but more patients will be recruited into the parent study
Depending on whether someone has already been randomized participants of the parent study will be invited to take part in the adjunct study in one of two ways Aim 1 only or All Aims First patients who have already been randomized will be asked to allow biopsies to be made of their rectal tissue during their 3- or 5-year follow-up colonoscopy Aim 1 Biopsies which will be used for our biomarker measurements are very tiny pieces of tissue that can be examined under the microscope Second patients who have not yet been randomized will be invited to participate more fully All Aims in the adjunct study This involves having outpatient rectal biopsies taken immediately after their first phone call their 1-year follow-up visit and 7 - 21 days before their 3- or 5-year follow-up colonoscopy Finally during their 3- or 5-year colonoscopy biopsies will be taken from three areas of the colon the rectum same area as the outpatient biopsies the sigmoid colon and the ascending colon From all of the biopsies taken from all of the visits and colon sites biomarker measurements will be of normal proteins that occur in the surface cells lining the colon Study researchers will then analyze whether calcium andor vitamin D affect these biomarkers and whether the effects predict who gets new polyps
Depending on whether someone has already been randomized participants of the parent study will be invited to take part in the adjunct study in one of two ways Aim 1 only or All Aims First patients who have already been randomized will be asked to allow biopsies to be made of their rectal tissue during their 3- or 5-year follow-up colonoscopy Aim 1 Biopsies which will be used for our biomarker measurements are very tiny pieces of tissue that can be examined under the microscope Second patients who have not yet been randomized will be invited to participate more fully All Aims in the adjunct study This involves having outpatient rectal biopsies taken immediately after their first phone call their 1-year follow-up visit and 7 - 21 days before their 3- or 5-year follow-up colonoscopy Finally during their 3- or 5-year colonoscopy biopsies will be taken from three areas of the colon the rectum same area as the outpatient biopsies the sigmoid colon and the ascending colon From all of the biopsies taken from all of the visits and colon sites biomarker measurements will be of normal proteins that occur in the surface cells lining the colon Study researchers will then analyze whether calcium andor vitamin D affect these biomarkers and whether the effects predict who gets new polyps
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA114456 | NIH | None | None |
| 0975-2005 | OTHER | Emory University | httpsreporternihgovquickSearchR01CA114456 |