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EpiCheck and Short-term Intensive Chemoresection in NMIBC

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ClinicalTrials.gov Identifier: NCT04162704
Recruitment Status : Recruiting
First Posted : November 14, 2019
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Maria Skydt Lindgren, Aarhus University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Bladder Cancer Device: EpiCheck

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
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Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EpiCheck and Short-term Intensive Chemoresection in NMIBC
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: EpiCheck
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. EpiCheck result 2 [ Time Frame: One to two months after short-term, intensive chemoresection ]
    Number of patients with discrepancy between EpiCheck score and clinical findings at the time of cystoscopy

  2. EpiCheck result 3 [ Time Frame: One to two months after short-term, intensive chemoresection ]
    Trend of the EpiCheck test over time (increase/decrease/stable score) and its correlation to complete/incomplete tumour response

  3. Urine cytology [ Time Frame: One to two months after short-term, intensive chemoresection ]
    Sensitivity, specificity, negative and positive predictive value for urine cytology


Biospecimen Retention:   Samples With DNA
Urin samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection
Criteria

Inclusion Criteria:

  • Patients with a known history of Ta HG with recurrent disease
  • Patients referred to short-term, intensive chemoresection
  • Patients older than 18 years

Exclusion Criteria:

  • Known allergy or intolerance to Mitomycin
  • Incontinence or small bladder capacity (< 100 mL)
  • Previous pelvic radiation therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162704


Contacts
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Contact: Maria S Lindgren, MD 30915431 ext 0045 maalin@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Maria S Lindgren, MD    30915431 ext 0045    maalin@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital
More Information
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Responsible Party: Maria Skydt Lindgren, Principal Investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04162704    
Other Study ID Numbers: 1-10-72-207-19
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases