Clinical trial · Observational
Detecting Transitional Cell Carcinoma From Haematuria
Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor
NCT03256877CI-TRIAL-00039770TransTuFocompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of having bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- All participants
- description
- Patients with haematuria.
Primary outcomes (1)
- measure
- Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.
- timeFrame
- Outcome measure will be assessed by 6 months after trial completion.
- description
- 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.
Secondary outcomes (1)
- measure
- Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.
- timeFrame
- Outcome measure will be assessed by 6 months after trial completion.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Capable of giving written informed consent * Age ≥18 years * Referral to haematuria clinic (gross or microscopic haematuria) Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.