A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer


Original post, click here
This study is currently recruiting participants.

See

Verified June 2017 by University of Hawaii

Sponsor:

Collaborators:

Fred Hutchinson Cancer Research Center

University of Texas

Information provided by (Responsible Party):

University of Hawaii

ClinicalTrials.gov Identifier:

NCT03193515

First received: June 17, 2017

Last updated: June 17, 2017

Last verified: June 2017

Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.

Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

Primary Outcome Measures:

Secondary Outcome Measures:

  • Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck. [ Time Frame: 2 years ]

    To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.

    To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.

Biospecimen Retention:   Samples With DNA

Urine collection (minimal 50 mL) and cystoscopy (+ biopsy w/in 4 weeks, if abnormal noted)

Estimated Enrollment: 300
Actual Study Start Date: December 30, 2016
Estimated Study Completion Date: December 30, 2022
Estimated Primary Completion Date: December 30, 2021 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Patients with a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance

Inclusion Criteria

Participants must be:

  • Age 18 years or older
  • Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
  • Participants may be treated with adjuvant intravesical therapy
  • Willing and able to give written informed consent (see Appendix 1)
  • Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

Exclusion Criteria:

Participants must not:

  • Have had radical cystectomy
  • History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years
  • Have a known active urinary tract infection or urinary retention
  • Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) – Serum creatinine value can be up to 60 days before consent, otherwise repeat.
  • Have ureteral stents, nephrostomy tubes or bowel interposition
  • Have recent genitourinary instrumentation (within 10 days prior to signing consent)
  • Be unable or unwilling to complete the surveillance regimen

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03193515

University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Contact: Charles Rosser, MD    808-586-2979      

University of Hawaii

Fred Hutchinson Cancer Research Center

University of Texas

Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT03193515     History of Changes
Other Study ID Numbers: Rosser-2015-6
Study First Received: June 17, 2017
Last Updated: June 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 20, 2017