Non-muscle Invasive Bladder Cancer Clinical Trial
Official title:
A Randomized Cross-Over Study to Evaluate Patient Preference and Satisfaction With Urine-based Molecular Testing Versus Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.
Status | Recruiting |
Enrollment | 107 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (NMIBC) who have at least 6 months of disease-free survival from last recurrence. - Able to provide urine for testing and comply with study protocol. - Have an email address and be willing to complete surveys online. Exclusion Criteria: - History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma) - Patients with predominant (>50%) variant histology - Patients with a history of upper tract and/or urethral cancer - Women who are pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preference for CxBladder Monitor compared to cystoscopy | Patient preference will be assessed based on the Preference Questionnaire (PQ) after completion of the study cross-over period (after both methods of testing have been experienced). | Up to 6 months | |
Secondary | Patient satisfaction | Patient satisfaction will be assessed based on the Satisfaction Questionnaire (SQ) after completion of each test at 3 and 6 months. | Up to 6 months | |
Secondary | Change in symptoms and function - EORTC NMIBC-24 | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer (EORTC NMIBC-24) will be used to assess Health-related quality of life. The questionnaire consists of 24 items scored on a four-point Likert scale ranging from 1 (not at all) to 4 (very much), with the exception of the global health status items, which employ a seven-point scale ranging from 1 (very poor) to 7 (excellent). Higher scores are interpreted as more symptom burden, with exception of the sexual function and sexual enjoyment sections, where higher scores represent better functioning. | Up to 6 months | |
Secondary | Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) | Health-related quality of life will be assessed based on the Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF) at baseline, 3 months (within 1 week of test), and 6 months (within 1 week of test). The nine-item FCRI evaluates the presence and severity of intrusive thoughts associated with FCR. Each item is rated on a Likert scale ranging from 0 ("not at all" or "never") to 4 ("a great deal' or "all the time"). A higher score indicates higher levels of FCR. | Up to 6 months | |
Secondary | Financial costs | Assessed by patient responses to questions about missed work and time missed from usual activities. | Up to 6 months | |
Secondary | Error rate identifying recurrent nonmuscle invasive bladder cancer (NMIBC) | Error rate for CxBladder is defined as the proportion of patients who have a negative CxBladder at 3 months but have a recurrence identified on cystoscopy at 6 months for patients in arm A. The error rate for cystoscopy is defined as the proportion of patients who have a negative cystoscopy at 3 months but have a positive CxBladder at 6 months that is subsequently confirmed by cystoscopy for patients in arm B. | Up to 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04736394 -
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
|
Phase 3 | |
Recruiting |
NCT05951179 -
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04943094 -
Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
|
||
Not yet recruiting |
NCT06227065 -
Precise Neoadjuvant Chemoresection of Low Grade NMIBC
|
Phase 2 | |
Completed |
NCT02969109 -
Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
|
||
Completed |
NCT01458847 -
Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer
|
Phase 1 | |
Recruiting |
NCT03914794 -
A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
|
Phase 2 | |
Recruiting |
NCT05126472 -
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
|
Phase 1 | |
Recruiting |
NCT04644835 -
Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer
|
N/A | |
Active, not recruiting |
NCT04100733 -
Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor
|
N/A | |
Recruiting |
NCT05085990 -
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
|
Phase 1 | |
Recruiting |
NCT03560479 -
A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01310803 -
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder
|
Phase 3 | |
Completed |
NCT03081858 -
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04498702 -
Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy
|
Phase 2 | |
Recruiting |
NCT05337397 -
Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
|
||
Active, not recruiting |
NCT04490993 -
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
|
Phase 3 | |
Recruiting |
NCT04859751 -
Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer
|
Phase 3 | |
Recruiting |
NCT05672615 -
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
|
||
Not yet recruiting |
NCT06245603 -
A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer
|
N/A |