Bladder CancerEarly Phase 1NCT02505516
BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS
A Early Phase 1 study testing metformin in people with Bladder Cancer and Diabetes, run by UFUOMA MILLER FAKPOR at 1 site in Ghana.
Trial summary
patients om metformin from diabetic clinic were checked for bladder cancer Read more about this study
- Who is it for?
- Ages 25 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Diabetes
- What is being tested?
- metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGhana
- Study dates
- Jun 2013to Feb 2014
- Phase
- Early Phase 1
- 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 25 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 150 people attending diabetic clinic
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS ON METFORMIN THERAPY IN A WEST AFRICA SUB-REGION
patients om metformin from diabetic clinic were checked for bladder cancer
- Conditions
- Bladder Cancer, Diabetes
- Being tested
- metformin
- Keywords
- pathology
- Medical subject headings
- Urinary Bladder Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminOther
Also called glucophage
| Study group | Role | What they receive |
|---|---|---|
| metformin | Placebo comparator | metformin 500mg Receives: Other: metformin |
| not on metformin | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of diabetic patients on metformin therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- UFUOMA MILLER FAKPOR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, UFUOMA MILLER FAKPOR, University of Cape Coast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505516
- Sponsor's protocol ID
- 021
- Status last verified
- Jul 2015
- First submitted
- 20 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS ON METFORMIN THERAPY IN A WEST AFRICA SUB-REGION
- ClinicalTrials.gov ID
- NCT02505516
- Acronym / sponsor ID
- 021
- Conditions
- Bladder Cancer, Diabetes
- Keywords
- pathology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- UFUOMA MILLER FAKPORUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Jul 2015 (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.
patients om metformin from diabetic clinic were checked for bladder cancer
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin | Placebo comparator | Other: metforminmetformin 500mg |
| not on metformin | No intervention | – |
Who may qualify
- Ages
- 25 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 150 people attending diabetic clinic
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metforminAlso: glucophage | Other | metformin |
Primary outcome
Number of diabetic patients on metformin therapy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing metformin in people with Bladder Cancer and Diabetes, run by UFUOMA MILLER FAKPOR at 1 site in Ghana.
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 0 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: finished, as of the sponsor's last update on 22 Jul 2015. 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 Ghana. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Number of diabetic patients on metformin therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 22 Jul 2015.