Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-27 @ 2:20 PM
Study NCT ID:
NCT03193528
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2017-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine collection (minimal 50 mL) and cystoscopy (+ biopsy w/in 4 weeks, if abnormal noted)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2017-06-17', 'studyFirstSubmitQcDate': '2017-06-17', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.', 'timeFrame': '1 year'}, {'measure': '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.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '38167321', 'type': 'DERIVED', 'citation': 'Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.'}, {'pmid': '38045238', 'type': 'DERIVED', 'citation': 'Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.'}]}, 'descriptionModule': {'briefSummary': 'To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.', 'detailedDescription': 'Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable.\n\nBecause of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Have documented or reported gross hematuria within 3 month of study enrollment\n* Willing and able to give written informed consent\n\nExclusion Criteria (patients must not):\n\n* Have history of BCa\n* History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years\n* Have a known active urinary tract infection or urinary retention\n* 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\n* Have ureteral stents, nephrostomy tubes or bowel interposition\n* Have recent genitourinary instrumentation (within 10 days prior to signing consent)\n* Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)'}, 'identificationModule': {'nctId': 'NCT03193528', 'briefTitle': 'A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer', 'orgStudyIdInfo': {'id': 'Rosser-2015-7'}, 'secondaryIdInfos': [{'id': 'R01CA198887', 'link': 'https://reporter.nih.gov/quickSearch/R01CA198887', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Oppenheim', 'role': 'CONTACT', 'email': 'Amy.Oppenheim@cshs.org', 'phone': '310-423-3713'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arnold Chin, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '14627', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward Messing, MD', 'role': 'CONTACT'}], 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yair Lotan', 'role': 'CONTACT', 'email': 'yair.lotan@utsouthwestern.edu', 'phone': '214-648-0389'}], 'facility': 'UT Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Nara', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takuto Shimizu, MD', 'role': 'CONTACT', 'phone': '+81-744-22-3051'}], 'facility': 'Department of Urology, Nara Medical University', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Nara', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Satoshi Anai, MD', 'role': 'CONTACT'}], 'facility': 'Nara Precfecture Seiwa Medical Center', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}], 'centralContacts': [{'name': 'Charles Rosser, MD', 'role': 'CONTACT', 'email': 'charles.rosser@cshs.org', 'phone': '310-423-5609'}], 'overallOfficials': [{'name': 'Charles Rosser, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nonagen Bioscience Corporation'}, {'name': 'Hideki Furuya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, {'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'Nara Medical University', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'Nonagen Bioscience Corporation', 'class': 'INDUSTRY'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of Rochester', 'class': 'OTHER'}, {'name': 'Nara Prefecture Seiwa Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Charles Rosser', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}