search
Back to results

Chemoprevention With Folic Acid

Primary Purpose

Colon Cancer, Adenoma, Colonic Polyps

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Folic Acid
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Asymptomatic individuals from the age of 18 -80 years, undergoing clinically indicated colonoscopy for colon polyps noted on screening flexible sigmoidoscopy or as routine surveillance for a history of colon polyps, who are found to have at least one adenoma > 0.5cm will be eligible for entry.

Sites / Locations

  • Department of Veterans Affairs

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 3, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT00018551
Brief Title
Chemoprevention With Folic Acid
Official Title
3389 Colorectal Adenoma: Chemoprevention With Folic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
Colorectal neoplasia is the second most common cancer in the United States and other Western countries with about 140,000 newly diagnosed cases per year in the United States with a mortality rate of about 40%. The identification of a specific natural or synthetic compound with the ability to reverse or suppress the process of colon carcinogenesis would have profound implication in the development of colorectal adenomas and their subsequent transformation to colon cancer. Furthermore, the establishment of a correlative relationship between biomarkers of cell proliferation, differentiation, apoptosis and adenoma recurrence would provide pivotal data required to elucidate cell signaling mechanisms in future colon cancer chemoprevention trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Adenoma, Colonic Polyps

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Folic Acid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Asymptomatic individuals from the age of 18 -80 years, undergoing clinically indicated colonoscopy for colon polyps noted on screening flexible sigmoidoscopy or as routine surveillance for a history of colon polyps, who are found to have at least one adenoma > 0.5cm will be eligible for entry.
Facility Information:
Facility Name
Department of Veterans Affairs
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chemoprevention With Folic Acid

We'll reach out to this number within 24 hrs