NCT00959491

Brief Summary

The purpose of the investigators study is to evaluate the diagnostic ability of a new immunological fecal occult blood test in Cuban patients undergoing colonoscopy .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 20, 2010

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

August 13, 2009

Last Update Submit

October 19, 2010

Conditions

ColonoscopyOccult BloodImmunologic Tests

Keywords

ColonoscopyOccult BloodFecal

Study Arms (1)

Colonoscopy indication

All outpatients referred to colonoscopy according to inclusion criteria in the specified period time of one year .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Residents of Havana City admitted at the investigation center.

You may qualify if:

  • Patients (men or women) that are \>18 years of age referred to colonoscopy.

You may not qualify if:

  • Visible rectal bleeding
  • Known diagnosis of inflammatory bowel disease
  • Hematuria
  • Menstruation at the time of obtaining a stool specimen
  • Patients taking medication such as non steroids anti inflammatory drugs and anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gastroenterology

Havana, La Habana, 10400, Cuba

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

One fecal sample

Study Officials

  • Luis C Bertot, MD

    National Institute of Gastroenterology , Havana, Cuba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

November 1, 2010

Last Updated

October 20, 2010

Record last verified: 2009-10

Locations

CU(1)