Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-30 @ 10:01 AM
Study NCT ID:
NCT03032835
Status:
RECRUITING
Last Update Posted:
2024-11-19
First Post:
2017-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partners Calciphylaxis Biobank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002115', 'term': 'Calciphylaxis'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, serum, DNA and tissue samples (e.g. skin)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with improvement in calciphylaxis skin lesions', 'timeFrame': '6 months', 'description': 'Skin lesions will be assessed by investigators at baseline (entry into study) and at 6 months to determine whether there is improvement. The investigators will determine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with >30% improvement in pain severity', 'timeFrame': '4weeks', 'description': 'Pain severity will be assessed by investigators at baseline (entry into study) and at 4 weeks to determine whether there is improvement. Pain is measured using Wong-Baker Faces pain rating scale. The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.'}, {'measure': 'Time to death in patients with calciphylaxis', 'timeFrame': 'Up to 5 years', 'description': 'Time to death is defined as time from the diagnosis of calciphylaxis to death (or to the end of follow up). The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calciphylaxis', 'Warfarin', 'Dialysis'], 'conditions': ['Calciphylaxis', 'Calcific Uremic Arteriolopathy', 'End Stage Renal Disease', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '28049648', 'type': 'BACKGROUND', 'citation': 'Nigwekar SU, Bloch DB, Nazarian RM, Vermeer C, Booth SL, Xu D, Thadhani RI, Malhotra R. Vitamin K-Dependent Carboxylation of Matrix Gla Protein Influences the Risk of Calciphylaxis. J Am Soc Nephrol. 2017 Jun;28(6):1717-1722. doi: 10.1681/ASN.2016060651. Epub 2017 Jan 3.'}, {'pmid': '27080977', 'type': 'BACKGROUND', 'citation': 'Nigwekar SU, Zhao S, Wenger J, Hymes JL, Maddux FW, Thadhani RI, Chan KE. A Nationally Representative Study of Calcific Uremic Arteriolopathy Risk Factors. J Am Soc Nephrol. 2016 Nov;27(11):3421-3429. doi: 10.1681/ASN.2015091065. Epub 2016 Apr 14.'}, {'pmid': '25960299', 'type': 'BACKGROUND', 'citation': 'Nigwekar SU, Kroshinsky D, Nazarian RM, Goverman J, Malhotra R, Jackson VA, Kamdar MM, Steele DJ, Thadhani RI. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015 Jul;66(1):133-46. doi: 10.1053/j.ajkd.2015.01.034. Epub 2015 May 7.'}, {'pmid': '36712824', 'type': 'DERIVED', 'citation': 'Wen W, Krinsky S, Kroshinsky D, Durant O, He J, Seethapathy R, Hillien SAS, Mengesha B, Malhotra R, Chitalia V, Nazarian RM, Goverman J, Lyons KS, Nigwekar SU. Patient-Reported and Clinical Outcomes Among Patients With Calciphylaxis. Mayo Clin Proc Innov Qual Outcomes. 2023 Jan 24;7(1):81-92. doi: 10.1016/j.mayocpiqo.2022.12.006. eCollection 2023 Feb.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed?term=((Nigwekar)%20AND%20((Calciphylaxis)%20OR%20(Calcific%20uremic%20arteriolopathy)))', 'label': 'Link to publications'}]}, 'descriptionModule': {'briefSummary': 'Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles.\n\nThere are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis.\n\nThe Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.', 'detailedDescription': 'Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles.\n\nThere are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis.\n\nThe Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.\n\nThis repository is working in collaboration with the Partners Biobank as they will still be receiving samples from the PCB and storing them and distributing them according to their own procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with skin lesions consistent with calciphylaxis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ≥18 years old\n2. Skin lesions consistent with calciphylaxis diagnosis as determined by the treating clinician\n3. Informed of the investigational nature of the study and sign written Informed consent OR are eligible for surrogate consent process based on impaired decision making\n\nExclusion Criteria:\n\n1. Patients \\<18 years of age\n2. Prisoners'}, 'identificationModule': {'nctId': 'NCT03032835', 'acronym': 'PCB', 'briefTitle': 'Partners Calciphylaxis Biobank', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Partners Calciphylaxis Biobank and Patient Registry', 'orgStudyIdInfo': {'id': '2016P002690'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study participants', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sagar U Nigwekar, MD, MMSc', 'role': 'CONTACT', 'email': 'snigwekar@mgh.harvard.edu', 'phone': '617-726-7872'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Sagar U Nigwekar, MD, MMSc', 'role': 'CONTACT', 'email': 'snigwekar@mgh.harvard.edu', 'phone': '617-726-7872'}], 'overallOfficials': [{'name': 'Sagar U Nigwekar, MD, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant in Medicine', 'investigatorFullName': 'Sagar U. Nigwekar, MD, MMSc', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}