Bladder CancerNCT02027649
Detection of K14 in Bladder Cancer With a Non Invasive Technique
An observational study of Bladder Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to May 2017
- How long will I take part?
- 2 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospital patients.
Who may be able to join
- Bladder cancer
Who cannot join
- Inability to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Corporació Sanitària i Universitària Parc Taulí
Sabadell, Barcelona, 08208
About this study
Official title: K14 in Urothelial Cells as a Pronostic and Diagnostic Marker in Bladder Cancer Patients Using a Non Invasive Technique.
By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer.
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Keratin 14, Pronostic marker, Diagnostic marker, Noninvasive technique
- Medical subject headings
- Urinary Bladder Neoplasms
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 |
|---|---|---|
| Bladder cancer | Patients who suffered a bladder cancer | |
| Control group | Patients with urologic diseases of non tumoral origin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratin 14
Measured: At the time of study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionMay 2017
Why it stopped: Absence of positive results
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Francisco Delgado de la Poza, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027649
- Sponsor's protocol ID
- K14 in bladder cancer
- Other IDs
- CIR2013
- Status last verified
- Jul 2017
- First submitted
- 3 Jan 2014
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- K14 in Urothelial Cells as a Pronostic and Diagnostic Marker in Bladder Cancer Patients Using a Non Invasive Technique.
- ClinicalTrials.gov ID
- NCT02027649
- Acronym / sponsor ID
- K14 in bladder cancer
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Keratin 14, Pronostic marker, Diagnostic marker, Noninvasive technique
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Absence of positive results
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Jan 2014 (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.
By an invasive technique keratin 14 has been identified as a prognostic factor in bladder cancer. This study aims to analyze whether through a non-invasive technique keratin 14 can be used as a diagnostic and prognostic marker for this cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer | – | –Patients who suffered a bladder cancer |
| Control group | – | –Patients with urologic diseases of non tumoral origin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients.
Key inclusion criteria (1 listed)
- Bladder cancer
Key exclusion criteria (1 listed)
- Inability to sign the informed consent
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
Keratin 14
Time frame: At the time of study entry
Results and safety
The study was stopped early (reason given: Absence of positive results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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?
An observational study of Bladder Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 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: stopped early, as of the sponsor's last update on 21 Jul 2017. 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 Spain. 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?
The study was stopped early (reason given: Absence of positive results). 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.
What does the primary outcome measure?
Keratin 14 (time frame: At the time of study entry). 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 21 Jul 2017.