ACTIVE_NOT_RECRUITING

A Diagnostic for the Early Detection of Bladder Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

Official Title

A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer

Quick Facts

Study Start:2022-04-29

Study Completion:2029-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05347342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 50 years or older 2. \>20 pack year history of tobacco exposure 3. Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible. 4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic 5. Willing and able to give written informed consent 6. Willing to provide voided urine sample 7. Be able and willing to complete semi-annual research clinic visits for 4 years	1. History of hematuria (microscopic or gross) within 2 years of signing consent. 2. Previous history of bladder cancer 3. A known active urinary tract infection or urinary retention 4. An active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat. 5. An ureteral stents, nephrostomy tubes or bowel interposition 6. A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)

Inclusion Criteria

Exclusion Criteria

1. Age 50 years or older
2. \>20 pack year history of tobacco exposure
3. Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
5. Willing and able to give written informed consent
6. Willing to provide voided urine sample
7. Be able and willing to complete semi-annual research clinic visits for 4 years

1. History of hematuria (microscopic or gross) within 2 years of signing consent.
2. Previous history of bladder cancer
3. A known active urinary tract infection or urinary retention
4. An active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.
5. An ureteral stents, nephrostomy tubes or bowel interposition
6. A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)

Contacts and Locations

Principal Investigator

Hideki Furuya

PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Study Locations (Sites)

Long Beach VA Healthcare System

Long Beach, California, 90712

United States

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

Hideki Furuya, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-29

Study Completion Date2029-01

Study Record Updates

Study Start Date2022-04-29

Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

Bladder Cancer