NCT04162704

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

November 12, 2019

Last Update Submit

August 10, 2021

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • EpiCheck result

    Number of patients with accordance between EpiCheck score and clinical findings at the time of evaluation cystoscopy

    One to two months after short-term, intensive chemoresection

Secondary Outcomes (3)

  • EpiCheck result 2

    One to two months after short-term, intensive chemoresection

  • EpiCheck result 3

    One to two months after short-term, intensive chemoresection

  • Urine cytology

    One to two months after short-term, intensive chemoresection

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection

You may qualify if:

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

You may not qualify if:

  • Known allergy or intolerance to Mitomycin
  • Incontinence or small bladder capacity (\< 100 mL)
  • Previous pelvic radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urin samples

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Maria S Lindgren, MD

CONTACT

30915431maalin@rm.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

October 28, 2019

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

August 11, 2021

Record last verified: 2021-08

Locations

DK(1)