NCT00018551

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1998

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

July 3, 2001

Last Update Submit

January 20, 2009

Conditions

Colon CancerAdenomaColonic Polyps

Interventions

Folic AcidDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Department of Veterans Affairs

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsAdenomaColonic Polyps

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

October 1, 1998

Study Completion

September 1, 2003

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations

US(1)