Urothelial CarcinomaPROTEHCTNCT04077359
Prospective Trial for Examining Hematuria Using Computed Tomography
A study testing CT in people with Urothelial Carcinoma and Renal Cell Carcinoma, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase CT (control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Renal Cell Carcinoma, Renal Cyst
- What is being tested?
- CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2019to 1 Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- Asymptomatic macroscopic hematuria referred to CTU before cystoscopy
- >18 years old
Who cannot join
- Symptomatic urinary tract infection relieved by antibiotics
- Patients referred to CTU after cystoscopy
- Cystoscopy within the last 6 months
- Symptomatic stone disease
- Macroscopic hematuria after recent catherization or instrumentation
- Microscopic hematuria
Show all 12Show fewer
- Previous history of Urothelial cell carcinoma
- Known staghorn calculi
- Allergy to iodine contrast media
- Impaired renal function (eGFR < 30m/min/1.73m2)
- Unable to provide consent for any reason
- For any reason, do not wish to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase CT (control).
Read the detailed description
Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine.
Study type: Prospective clinical trial
Study design: One sample paired proportion, non-inferiority study with a 7.5% non-inferiority limit.
Investigational product: One phase nephrographic CT (experimental arm) vs. Four-phase CT (control arm)
Objective:The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with asymptomatic macroscopic hematuria compared to the traditional four-phase CT (control).
Primary endpoints: The difference in accuracy between the experimental- and control arm.
there will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm
Sample size: 250 patients
- Conditions
- Urothelial Carcinoma, Renal Cell Carcinoma, Renal Cyst, Renal Stone
- Being tested
- CT
- Medical subject headings
- Carcinoma, Transitional Cell, Carcinoma, Renal Cell, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDiagnostic test
the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
| Study group | Role | What they receive |
|---|---|---|
| nephrographic phase CT | Experimental | the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series Receives: Diagnostic Test: CT |
| gold standard | Active comparator | all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm Receives: Diagnostic Test: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy for detecting urothelial cell carcinomas
the accuracy of the experimental arm will not be worse than the accuracy of the control CT by a margin of more than 7.5%
Measured: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year
Secondary outcomes (8)
false negative rate
The difference in false negative rates
Measured: all examinations are evaluated immediately after the CT examination
false positive rate
The difference in false positive rates
Measured: all examinations are evaluated immediately after the CT examination
renal cell carcinoma detection rates
The detection rates in the two arms
Measured: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year
Area under the curve (AUC)
the difference in AUC of the two arms
Measured: all examinations are evaluated immediately after the CT examination
predictive values
The difference in the predictive values of the two arms
Measured: all examinations are evaluated immediately after the CT examination
Detection or urinary calculi
The difference in detection of the two arms
Measured: all examinations are evaluated immediately after the CT examination
Detection of Bosniak cyst
The difference in detection in the two arms
Measured: all examinations are evaluated immediately after the CT examination
Interobserver variability
The agreement and variability between primary and secondary readers
Measured: all examinations are evaluated immediately after the CT examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start15 Sep 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One sample, paired, non-inferiority study with a 7.5% non-inferiority limit. Each patient undergo the experimental CT and the control CT
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Rud, Oslo University Hospital
- Investigators
- Erik Rud, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077359
- Sponsor's protocol ID
- 2019/395
- Acronym
- PROTEHCT
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2019
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial for Examining Hematuria Using Computed Tomography
- ClinicalTrials.gov ID
- NCT04077359
- Acronym / sponsor ID
- PROTEHCT / 2019/395
- Conditions
- Urothelial Carcinoma, Renal Cell Carcinoma, Renal Cyst, Renal Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 4 Sep 2019 (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.
The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase CT (control).
Detailed description
Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine.
Study type: Prospective clinical trial
Study design: One sample paired proportion, non-inferiority study with a 7.5% non-inferiority limit.
Investigational product: One phase nephrographic CT (experimental arm) vs. Four-phase CT (control arm)
Objective:The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with asymptomatic macroscopic hematuria compared to the traditional four-phase CT (control).
Primary endpoints: The difference in accuracy between the experimental- and control arm.
there will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm
Sample size: 250 patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One sample, paired, non-inferiority study with a 7.5% non-inferiority limit. Each patient undergo the experimental CT and the control CT
| Arm | Type | Receives |
|---|---|---|
| nephrographic phase CT | Experimental | Diagnostic Test: CTthe nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series |
| gold standard | Active comparator | Diagnostic Test: CTall series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic macroscopic hematuria referred to CTU before cystoscopy
- >18 years old
Key exclusion criteria (12 listed)
- Symptomatic urinary tract infection relieved by antibiotics
- Patients referred to CTU after cystoscopy
- Cystoscopy within the last 6 months
- Symptomatic stone disease
- Macroscopic hematuria after recent catherization or instrumentation
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 |
|---|---|---|
| CTthe CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase. | Diagnostic test | gold standard, nephrographic phase CT |
Primary outcome
accuracy for detecting urothelial cell carcinomas
Time frame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year
the accuracy of the experimental arm will not be worse than the accuracy of the control CT by a margin of more than 7.5%
8 secondary outcomes
false negative rate
Time frame: all examinations are evaluated immediately after the CT examination
false positive rate
Time frame: all examinations are evaluated immediately after the CT examination
renal cell carcinoma detection rates
Time frame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year
Area under the curve (AUC)
Time frame: all examinations are evaluated immediately after the CT examination
predictive values
Time frame: all examinations are evaluated immediately after the CT examination
Detection or urinary calculi
Time frame: all examinations are evaluated immediately after the CT examination
Detection of Bosniak cyst
Time frame: all examinations are evaluated immediately after the CT examination
Interobserver variability
Time frame: all examinations are evaluated immediately after the CT examination
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 6 Sep 2022.
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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.
Erik Rud principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT in people with Urothelial Carcinoma and Renal Cell Carcinoma, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 12 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 6 Sep 2022. 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 Norway. 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?
accuracy for detecting urothelial cell carcinomas (time frame: all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year). 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 6 Sep 2022.