Bladder CancerNCT04162704
EpiCheck and Short-term Intensive Chemoresection in NMIBC
An observational study of Bladder Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- EpiCheck
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Oct 2019to Oct 2022
- 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: Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection
Who may be able to join
- Patients with a known history of Ta HG with recurrent disease
- Patients referred to short-term, intensive chemoresection
- Patients older than 18 years
Who cannot join
- Known allergy or intolerance to Mitomycin
- Incontinence or small bladder capacity (< 100 mL)
- Previous pelvic radiation therapy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Maria S Lindgren, MD, 30915431 ext. 0045, maalin@rm.dk
About this study
The aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin.
Read the detailed description
The study will be conducted as an exploratory, prospective observational study. Participants consists of patients referred to short-term, intensive chemoresection due to recurrent NMIBC. The treatment adhere to the regimen described in the NICSA trial with the ClinicalTrials.gov identifier NCT03348969. Treatment consists of short-term, intensive chemoresection with Mitomycin; 40 mg is administered intravesically three times a week for two weeks. To evaluate tumour response, an early cystoscopy is performed in the outpatient clinic one to two months after treatment completion. No visible tumour and residual tumour with benign histology is considered complete response. Residual tumour tissue with neoplastic histology is considered incomplete response and will be treated with TURBT or tumour fulguration. Subsequently patients continue a standardized follow-up program as Danish guidelines prescribe which is initiated after four months.
- Conditions
- Bladder Cancer
- Being tested
- EpiCheck
- 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.
EpiCheckDevice
If the EpiCheck test is positive at the time of inclusion, the test is repeated prior to the fourth and sixth instillation with Mitomycin as well as prior to the subsequent two cystoscopies. If the EpiCheck test is negative at the time of inclusion, no further tests will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
EpiCheck result
Number of patients with accordance between EpiCheck score and clinical findings at the time of evaluation cystoscopy
Measured: One to two months after short-term, intensive chemoresection
Secondary outcomes (3)
EpiCheck result 2
Number of patients with discrepancy between EpiCheck score and clinical findings at the time of cystoscopy
Measured: One to two months after short-term, intensive chemoresection
EpiCheck result 3
Trend of the EpiCheck test over time (increase/decrease/stable score) and its correlation to complete/incomplete tumour response
Measured: One to two months after short-term, intensive chemoresection
Urine cytology
Sensitivity, specificity, negative and positive predictive value for urine cytology
Measured: One to two months after short-term, intensive chemoresection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start28 Oct 2019
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
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.
- More trials run by Aarhus 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Skydt Lindgren, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162704
- Sponsor's protocol ID
- 1-10-72-207-19
- Status last verified
- Aug 2021
- First submitted
- 12 Nov 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpiCheck and Short-term Intensive Chemoresection in NMIBC
- ClinicalTrials.gov ID
- NCT04162704
- Acronym / sponsor ID
- 1-10-72-207-19
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 14 Nov 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 aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin.
Detailed description
The study will be conducted as an exploratory, prospective observational study. Participants consists of patients referred to short-term, intensive chemoresection due to recurrent NMIBC. The treatment adhere to the regimen described in the NICSA trial with the ClinicalTrials.gov identifier NCT03348969. Treatment consists of short-term, intensive chemoresection with Mitomycin; 40 mg is administered intravesically three times a week for two weeks. To evaluate tumour response, an early cystoscopy is performed in the outpatient clinic one to two months after treatment completion. No visible tumour and residual tumour with benign histology is considered complete response. Residual tumour tissue with neoplastic histology is considered incomplete response and will be treated with TURBT or tumour fulguration. Subsequently patients continue a standardized follow-up program as Danish guidelines prescribe which is initiated after four months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection
Key inclusion criteria (3 listed)
- Patients with a known history of Ta HG with recurrent disease
- Patients referred to short-term, intensive chemoresection
- Patients older than 18 years
Key exclusion criteria (3 listed)
- Known allergy or intolerance to Mitomycin
- Incontinence or small bladder capacity (< 100 mL)
- Previous pelvic radiation therapy
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 |
|---|---|---|
| EpiCheckIf the EpiCheck test is positive at the time of inclusion, the test is repeated prior to the fourth and sixth instillation with Mitomycin as well as prior to the subsequent two cystoscopies. If the EpiCheck test is negative at the time of inclusion, no further tests will be performed. | Device | – |
Primary outcome
EpiCheck result
Time frame: One to two months after short-term, intensive chemoresection
Number of patients with accordance between EpiCheck score and clinical findings at the time of evaluation cystoscopy
3 secondary outcomes
EpiCheck result 2
Time frame: One to two months after short-term, intensive chemoresection
EpiCheck result 3
Time frame: One to two months after short-term, intensive chemoresection
Urine cytology
Time frame: One to two months after short-term, intensive chemoresection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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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.
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 Aarhus University Hospital at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 2021. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria S Lindgren, MD (30915431 ext. 0045, maalin@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EpiCheck result (time frame: One to two months after short-term, intensive chemoresection). 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 11 Aug 2021.