Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 12:47 PM
Study NCT ID:
NCT04669860
Status:
SUSPENDED
Last Update Posted:
2025-09-08
First Post:
2020-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563477', 'term': 'Nephrolithiasis, Calcium Oxalate'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'the microbiome of voided urine, bladder urine, stone fragments, and tissue from renal papillary biopsies in patients with CO stones.\n\nThe microbiome of urine from the bladder, tissue from the renal tumor, and tissue from surrounding healthy renal tissue in patients with RCC\n\nVoided urine sample from healthy volunteers.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial community structure in patients with CO urolithiasis', 'timeFrame': 'Day 1', 'description': 'Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from mid-stream voided urine sample, urine sample collected from the bladder, kidney stone fragment, and a renal papillae biopsy specimen.'}, {'measure': 'Microbial community structure in patients with RCC', 'timeFrame': 'Day 1', 'description': 'Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from catheterized urine specimen from the bladder, a biopsy of the tumor, and a biopsy of normal-appearing renal papillae specimen.'}, {'measure': 'Microbial community structure in healthy participants', 'timeFrame': 'Day 1', 'description': 'Alpha and beta diversity, principal coordinate analysis, and phylogenetic trees of the bacterial and fungal microbial community from clean-catch urine specimen.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['calcium oxalate stones', 'renal cell carcinoma', 'microbiome', 'urinary microbiome'], 'conditions': ['Calcium Oxalate Urolithiasis', 'Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to identify bacterial and fungal microbiome associated with calcium oxalate (CO) urolithiasis and renal cell carcinoma (RCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Healthy participants\n2. Participants with CO urolithiasis scheduled for endoscopic kidney stone removal surgery.\n3. Participants with RCC who are scheduled for kidney removal surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults that are able to consent (≥ 18 years of age)\n* No history of asymptomatic bacteriuria or Urinary Tract Infection within the past 1 month\n* No history of coagulopathy and not on anticoagulant or antiplatelet medication at the time of surgery.\n* For patients with urolithiasis, must not have a history of RCC\n* For patients with RCC, must not have a history of urolithiasis\n* Controls must have no history of stones, RCC, or urinary tract infection (within 1 month).\n* For all participants, no antimicrobial treatment within the past month\n\nExclusion Criteria:\n\n* Adults unable to consent\n* For patients with urolithiasis, technical difficulty in taking renal papillae biopsy.\n* History of urinary tract infection within the past 1 month\n* History of coagulopathy and on anticoagulants or antiplatelets that could not be stopped perioperatively.\n* Patients with nephrolithiasis and renal tumors with positive preoperative urine cultures- suggesting asymptomatic bacteriuria.\n* For patients with urolithiasis, a history of RCC\n* For patients with RCC, a history of urolithiasis\n* Controls who have a history of stones, RCC, or urinary tract infection.\n* For all participants, antimicrobial treatment within the past month.'}, 'identificationModule': {'nctId': 'NCT04669860', 'briefTitle': 'Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Evaluating the Bacterial and Fungal Microbiome in Patients With Calcium Oxalate Urolithiasis and Renal Cell Carcinoma.', 'orgStudyIdInfo': {'id': '20200100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'calcium oxalate urolithiasis group', 'description': 'Participants with CO urolithiasis scheduled for definitive endoscopic stone removal will be evaluated to identify bacterial and fungal microbiome in mid-stream voided urine sample, urine sample collected from the bladder, kidney stone fragment, and a renal papillae biopsy specimen.'}, {'label': 'renal cell carcinoma group', 'description': 'Participants with RCC scheduled for definitive kidney removal surgery will be evaluated to identify bacterial and fungal microbiome in a catheterized urine specimen from the bladder, a biopsy of the tumor, and a biopsy of normal-appearing renal papillae specimen.'}, {'label': 'healthy control group', 'description': 'The participants will provide a clean-catch voided midstream urine sample to identify bacterial and fungal microbiome.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Hemendra N Shah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of clinical Urology', 'investigatorFullName': 'Hemendra Shah', 'investigatorAffiliation': 'University of Miami'}}}}