Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06126796
Other study ID # MDT-CxB-01
Secondary ID 23-008567NCI-202
Status Recruiting
Phase
First received
Last updated
Start date November 16, 2023
Est. completion date November 2024

Study information

Verified date May 2024
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CxBladder Monitor
CxBladder Monitor (CxbM) is an FDA-approved genomic biomarker test specifically designed for patients undergoing surveillance for NMIBC. The non-invasive urine test quantifies 5 measured biomarker genes (MDK, HOXA13, CDC2 (CDK1), IGFBP5, CXCR2) and incorporates this information into an algorithm to detect the presence or absence of bladder cancer.
Cystoscopy
Cystoscopy is the most common way surveillance has been performed for NMIBC. Cystoscopy is a procedure that allows your doctor to examine the lining of your bladder and the tube that carries urine out of your body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into your bladder.

Locations

Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  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

External Links