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Chemoprevention With Folic Acid

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00018551
  Purpose

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.


Condition Intervention Phase
Colon Cancer
Adenoma
Colonic Polyps
Drug: Folic Acid
Phase II

MedlinePlus related topics:   Cancer    Colonic Polyps   

ChemIDplus related topics:   Folic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:   3389 Colorectal Adenoma: Chemoprevention With Folic Acid

Further study details as provided by Department of Veterans Affairs:

Study Start Date:   October 1998
Estimated Study Completion Date:   September 2003

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018551

Locations
United States, Michigan
Department of Veterans Affairs    
      Detroit, Michigan, United States, 48201

Sponsors and Collaborators
  More Information


Study ID Numbers:   ONCO-021-98S
First Received:   July 3, 2001
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00018551
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Colonic Polyps
Polyps
Intestinal Diseases
Intestinal Neoplasms
Folic Acid
Digestive System Diseases
Gastrointestinal Neoplasms
Adenoma
Colonic Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Vitamin B Complex
Hematinics
Growth Substances
Physiological Effects of Drugs
Hematologic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Intestinal Polyps
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on October 10, 2008




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