Transitional Cell CarcinomaTransTuFoNCT03256877
Detecting Transitional Cell Carcinoma From Haematuria
An observational study of Transitional Cell Carcinoma, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Carcinoma
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2016to 16 May 2019
- 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: Study participants will be recruited from all patients referred to the haematuria clinic due to gross (visible) haematuria or findings on routine urinalysis suggestive of microscopic haematuria. These patients will be undergoing routine investigative cystoscopy on suspicion of urothelial cancer.
Who may be able to join
- Capable of giving written informed consent
- Age ≥18 years
- Referral to haematuria clinic (gross or microscopic haematuria)
Who cannot join
- Inability to provide written informed consent
- Previous radiotherapy to the bladder (e.g. prostate cancer)
- Active urinary tract infection (Patients may be re-approached at later opportunity when urinary infection is cleared and haematuria persists)
- Current or planned treatment with neoadjuvant chemotherapy or radiotherapy
- Other known malignant condition, either active or in complete remission ≤5 years
- HIV, hepatitis C, or any other known communicable disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor
To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.
Read the detailed description
The effective diagnosis of transitional cell carcinoma (TCC), the most common form of bladder cancer, is often quite challenging, due to a lack of disease-specific symptoms. Detecting TCC early is crucial to increase the chances of a cure. Cystoscopy, which is currently the standard test used for urothelial cancer diagnosis, is an invasive and relatively expensive procedure but, while several potential markers in urine have been studied with the goal of replacing cystoscopy, no urinary marker alone or in combination with others has shown sufficient accuracy.
In this study, levels of tissue factor (TF) isoforms will be measured by ELISA in urine samples collected from patients referred to the haematuria clinic with visible or microscopic haematuria. These values will be linked to the subsequent diagnosis of each patient, and used to assess the accuracy of the ELISAs in detecting TCC when compared to standard cystoscopy.
- Conditions
- Transitional Cell Carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
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 |
|---|---|---|
| All participants | Patients with haematuria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.
To examine the specificity and sensitivity of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria. The assays will provide measurements of the TF isoform concentrations present in patient urine samples, and the information on a subsequent diagnosis (or non-diagnosis) of a urothelial cancer will be obtained through reference to medical records.
Measured: Outcome measure will be assessed by 6 months after trial completion.
Secondary outcomes (1)
Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.
To determine the positive and negative predictive values of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria.
Measured: Outcome measure will be assessed by 6 months after trial completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start18 Oct 2016
- Primary completion28 May 2018
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Cell CarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- C-Term Diagnostics Ltd, University of Hull
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256877
- Sponsor's protocol ID
- R2006
- Acronym
- TransTuFo
- Status last verified
- Jul 2019
- First submitted
- 15 Aug 2017
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor
- ClinicalTrials.gov ID
- NCT03256877
- Acronym / sponsor ID
- TransTuFo / R2006
- Conditions
- Transitional Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- C-Term Diagnostics Ltd, University of Hull
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- 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.
To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.
Detailed description
The effective diagnosis of transitional cell carcinoma (TCC), the most common form of bladder cancer, is often quite challenging, due to a lack of disease-specific symptoms. Detecting TCC early is crucial to increase the chances of a cure. Cystoscopy, which is currently the standard test used for urothelial cancer diagnosis, is an invasive and relatively expensive procedure but, while several potential markers in urine have been studied with the goal of replacing cystoscopy, no urinary marker alone or in combination with others has shown sufficient accuracy.
In this study, levels of tissue factor (TF) isoforms will be measured by ELISA in urine samples collected from patients referred to the haematuria clinic with visible or microscopic haematuria. These values will be linked to the subsequent diagnosis of each patient, and used to assess the accuracy of the ELISAs in detecting TCC when compared to standard cystoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | –Patients with haematuria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from all patients referred to the haematuria clinic due to gross (visible) haematuria or findings on routine urinalysis suggestive of microscopic haematuria. These patients will be undergoing routine investigative cystoscopy on suspicion of urothelial cancer.
Key inclusion criteria (3 listed)
- Capable of giving written informed consent
- Age ≥18 years
- Referral to haematuria clinic (gross or microscopic haematuria)
Key exclusion criteria (6 listed)
- Inability to provide written informed consent
- Previous radiotherapy to the bladder (e.g. prostate cancer)
- Active urinary tract infection (Patients may be re-approached at later opportunity when urinary infection is cleared and haematuria persists)
- Current or planned treatment with neoadjuvant chemotherapy or radiotherapy
- Other known malignant condition, either active or in complete remission ≤5 years
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
Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.
Time frame: Outcome measure will be assessed by 6 months after trial completion.
To examine the specificity and sensitivity of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria. The assays will provide measurements of the TF isoform concentrations present in patient urine samples, and the information on a subsequent diagnosis (or non-diagnosis) of a urothelial cancer will be obtained through reference to medical records.
1 secondary outcome
Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.
Time frame: Outcome measure will be assessed by 6 months after trial completion.
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 29 Jul 2019.
- Individual participant dataSharing planned: No
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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 Transitional Cell Carcinoma, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 6 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 29 Jul 2019. 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 United Kingdom. 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 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?
Specificity and sensitivity of the ELISAs when compared to standard cystoscopy. (time frame: Outcome measure will be assessed by 6 months after trial completion.). 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 29 Jul 2019.