Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-04-07 @ 4:16 PM
Study NCT ID:
NCT02346435
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney 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': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2015-01-20', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-specific survival', 'timeFrame': '5 years', 'description': 'Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years.'}], 'secondaryOutcomes': [{'measure': 'Objective Safety and Tolerability of Percutaneous Renal Biopsy', 'timeFrame': '5 years', 'description': 'Measured by observed total (minor and major) complications compared to historical complication rates for this procedure.'}, {'measure': 'Quality-of-life outcomes for patients undergoing AS versus definitive therapy.', 'timeFrame': '5 years', 'description': 'Measured by SF12 Questionnaire at enrollment, 6 and 12 months and annually thereafter.'}, {'measure': 'To determine objective selection criteria for active surveillance.', 'timeFrame': '5 years', 'description': 'Demographic (i.e. age, sex, race), clinical (i.e. comorbidities, medications, family history) and imaging characteristics (i.e. tumor size, enhancement patterns, tumor complexity) will be used to determine patients most suitable for active surveillance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['small renal mass', 'active surveillance'], 'conditions': ['Kidney Neoplasm']}, 'descriptionModule': {'briefSummary': 'Retrospective studies indicate that active surveillance for clinically localized, small renal masses (cT1a, \\<=4cm) is safe. It is our hypothesis that active surveillance is safe and efficacious when compared prospectively to patients undergoing immediate intervention for their small renal mass.', 'detailedDescription': 'All patients are offered active surveillance or immediate intervention, as applicable, prior to being offered consent for the DISSRM Registry. All patients are enrolled and followed prospectively. Surveillance patients are followed per protocol with serial imaging, blood work and quality of life questionnaires. Intervention patients are followed at the discretion of the attending surgeon with serial QOL appointments/questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, \\<=4cm).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a solid, enhancing renal mass ≤4cm at its greatest dimension found on incidental scanning in the last 6 months.\n* Age ≥ 18 and able to read, understand and sign informed consent.\n* Must be willing to adhere to the treatment algorithm and time constraints therein.\n\nExclusion Criteria:\n\n* Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.'}, 'identificationModule': {'nctId': 'NCT02346435', 'acronym': 'DISSRM', 'briefTitle': 'The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry', 'orgStudyIdInfo': {'id': '17821'}, 'secondaryIdInfos': [{'id': 'NA_00016036', 'type': 'OTHER', 'domain': 'AbramsonCC'}, {'id': '850179', 'type': 'OTHER', 'domain': 'UPenn IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active Surveillance'}, {'label': 'Immediate Intervention', 'description': 'May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation.'}, {'label': 'Crossover (Delayed Intervention)', 'description': 'Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Phillip M Pierorazio, MD', 'role': 'CONTACT', 'email': 'philpierorazio@jhmi.edu', 'phone': '410-502-5984'}, {'name': 'Phillip M Pierorazio, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohamad E Allaf, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Nirmish Singla', 'role': 'CONTACT', 'email': 'nsingla2@jhmi.edu', 'phone': '410-502-3692'}, {'name': 'Tina Driscoll', 'role': 'CONTACT', 'email': 'twlajni1@jhmi.edu'}], 'overallOfficials': [{'name': 'Mohamad E Allaf, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Nirmish Singla', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Comprehensive Cancer Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}