Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 9:42 PM
Study NCT ID:
NCT04960956
Status:
TERMINATED
Last Update Posted:
2022-03-14
First Post:
2021-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycosylation of Exosomes in Prostate and Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine sample collection, handling, and storage requirements\n\n* Collect at least 40-50 mL of fresh fasting urine (Note: up to 200 mL from each subject can be used for this study)\n* Within two hours of collection, add one tablet containing protease inhibitor cocktail and 0.5 mL of 2% sodium azide solution (weight to volume in water) to the sample for preventing bacterial growth (both additives provided by the Novotny Glycoscience Laboratory). Close the cap and mix gently by hand until the additives have dispersed into the urine sample.\n* Label the sample with the study ID, subject ID, date and time of collection\n* Store at -80°C\n* Batch-ship samples on dry ice to:\n\nProfessor Milos Novotny IU Department of Chemistry 800 E. Kirkwood Ave. Bloomington, IN 47405 Phone: 812-855-4532'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Could not identify a replacement Principal Investigator.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-09', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The concentration of urine spermine in the diagnosis of prostate and urothelial cancer', 'timeFrame': 'Baseline (one-time point)', 'description': 'xFresh urine will be collected for MALDI-TOF analysis to detect the concentration of exosome-derived glycans in the urine sample'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glycosylation', 'Urinary Exosomes', 'Exosome-derived Glycans'], 'conditions': ['Prostate Cancer', 'Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect a urine sample from patients with prostate and urothelial (bladder) cancer and healthy volunteers who do not have cancer, so that researchers can perform studies on microcellular structures called exosomes that may eventually lead to a new type of urinary biomarker test for prostate and urothelial cancer.', 'detailedDescription': 'This is a one-time participation, banking study of up to 40 subjects (10 prostate, 10 urothelial, 20 without cancer). Subjects must meet eligibility at the time of informed consent and will donate approx. 200mL of urine sample.\n\nPrimary Objective:\n\nTo develop alternative and efficient urinary exosome isolation and glycan analysis approaches for especially large glycan structures, including their isomers present at low levels, which will particularly enhance current analytical technology.\n\nTo provide further testing of the current microfluidic-based approaches developed to screen glycan samples which this additional specimen will provide to assess whether the current analytical techniques are robust enough to handle this type of sample with sufficient resolution and sensitivity for useful analytical information.\n\nTo compare alterations in exosome-derived glycans in adults with prostate and urothelial carcinoma in comparison with the exosome-derived glycans in age-matched healthy adults for assessment of findings to explore if the tools could be applied for future study toward a liquid biopsy test.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males ≥ 18 years old at the time of informed consent', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Willingness to donate a fasting urine sample for research Patient Cohort\n\n 1. Histologically confirmed prostate or urothelial carcinoma\n 2. Localized disease\n 3. No neoadjuvant chemotherapy for disease Healthy Volunteer Cohort\n\n <!-- -->\n\n 1. Healthy volunteers must not have prostate or urothelial carcinoma\n\nExclusion Criteria:\n\n1. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety\n2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent"}, 'identificationModule': {'nctId': 'NCT04960956', 'briefTitle': 'Glycosylation of Exosomes in Prostate and Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Glycosylation of Exosomes in Prostate and Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'IUSCC-0588'}}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin & Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Roberto Pili, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine, Indiana University Simon Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean for Cancer Research and Integrative Oncology', 'investigatorFullName': 'Roberto Pili', 'investigatorAffiliation': 'University at Buffalo'}}}}