ColonoscopyRLHVNCT00959491
A Prospective Study of a New Immunological Fecal Occult Blood Test
An observational study of Colonoscopy and Occult Blood, run by National Institute of Gastroenterology, Cuba at 1 site in Cuba.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Occult Blood, Immunologic Tests
- How many people
- 160 participants
- Where
- 1 siteCuba
- Study dates
- Oct 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Havana City admitted at the investigation center.
Who may be able to join
- Patients (men or women) that are >18 years of age referred to colonoscopy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy
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 .
Read the detailed description
Colorectal cancer is a major cause of cancer deaths in many countries. Therefore, the importance of screening for the early detection of colorectal cancer is evident. Fecal occult blood screening is proving to be an effective tool for detecting premalignant adenomas and colon cancer since the guaiac-based test was introduced in the late 1960s. However, several immunochemical fecal occult blood tests (IFOBTs) have become commercially available and the majority of these have demonstrated equal or superior sensitivities and specificities than the guaiac-based tests. Therefore, IFOBTs are replacing guaiac based tests despite their higher costs.In this study we evaluate the diagnostic accuracy of a new IFOBT and compare with the findings on colonoscopy.
- Conditions
- Colonoscopy, Occult Blood, Immunologic Tests
- Keywords
- Colonoscopy, Occult Blood, Fecal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy indication | All outpatients referred to colonoscopy according to inclusion criteria in the specified period time of one year . |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Gastroenterology, Cuba
- Sponsor type
- University, hospital or other
- Investigators
- Luis C Bertot, MD, Principal investigator, National Institute of Gastroenterology , Havana, Cuba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959491
- Sponsor's protocol ID
- RH-9
- Acronym
- RLHV
- Status last verified
- Oct 2009
- First submitted
- 13 Aug 2009
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy
- ClinicalTrials.gov ID
- NCT00959491
- Acronym / sponsor ID
- RLHV / RH-9
- Conditions
- Colonoscopy, Occult Blood, Immunologic Tests
- Keywords
- Colonoscopy, Occult Blood, Fecal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Institute of Gastroenterology, CubaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Colorectal cancer is a major cause of cancer deaths in many countries. Therefore, the importance of screening for the early detection of colorectal cancer is evident. Fecal occult blood screening is proving to be an effective tool for detecting premalignant adenomas and colon cancer since the guaiac-based test was introduced in the late 1960s. However, several immunochemical fecal occult blood tests (IFOBTs) have become commercially available and the majority of these have demonstrated equal or superior sensitivities and specificities than the guaiac-based tests. Therefore, IFOBTs are replacing guaiac based tests despite their higher costs.In this study we evaluate the diagnostic accuracy of a new IFOBT and compare with the findings on colonoscopy.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy indication | – | –All outpatients referred to colonoscopy according to inclusion criteria in the specified period time of one year . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Havana City admitted at the investigation center.
Key inclusion criteria (1 listed)
- Patients (men or women) that are >18 years of age referred to colonoscopy.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis C Bertot, MD principal investigator
National Institute of Gastroenterology , Havana, Cuba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Occult Blood, run by National Institute of Gastroenterology, Cuba at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2010.