Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 9:28 AM
Study NCT ID:
NCT05567133
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2022-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Indicators of Sarcoidosis Evolution-Unified Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017565', 'term': 'Sarcoidosis, Pulmonary'}, {'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples for serum isolation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2022-09-30', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Forced Vital Capacity in Liters', 'timeFrame': 'Baseline and 24 months', 'description': 'Forced vital capacity (FVC) is the total amount of air in liters exhaled during a forced maneuver.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcoid, lung, immune'], 'conditions': ['Sarcoidosis, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '37012011', 'type': 'DERIVED', 'citation': 'Drake WP, Hsia C, Samavati L, Yu M, Cardenas J, Gianella FG, Boscardin J, Koth LL. Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP): protocol for a multi-centre, longitudinal, observational study to identify clinical features that are predictive of sarcoidosis progression. BMJ Open. 2023 Apr 3;13(4):e071607. doi: 10.1136/bmjopen-2023-071607.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.', 'detailedDescription': 'The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit.\n\nPrimary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis.\n\nSecondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period.\n\nThe investigators will measure two types of blood markers to achieve this goal:\n\n* Clinically available blood markers that are available in most clinical labs\n* Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults who meet criteria for the diagnosis of pulmonary sarcoidosis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults with a diagnosis of sarcoidosis over the age of 18\n2. Case definition: we will follow the 1999 statement on sarcoidosis published by the American Thoracic Society for diagnosis which includes tissue biopsy confirmation and exclusion of alternative diagnoses including beryllium sensitization/chronic beryllium disease, mycobacterial, viral, and/or fungal infection\n\nExclusion Criteria:\n\n1. Inability to tolerate study procedures as determined by the investigator\n2. Pregnant or breastfeeding\n3. Concurrent medical diagnoses that would influence the expression of biomarkers will be considered an exclusion criterion. This includes diseases such as common variable immunodeficiency, HIV infection, or autoimmune diseases\n4. Concurrent interstitial lung diseases such as hypersensitivity pneumonitis or idiopathic pulmonary fibrosis\n5. Hematocrit (Packed Cell Volume) \\< 25%'}, 'identificationModule': {'nctId': 'NCT05567133', 'acronym': 'RISE-UP', 'briefTitle': 'Risk Indicators of Sarcoidosis Evolution-Unified Protocol', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis', 'orgStudyIdInfo': {'id': 'P0551258'}}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wonder P Drake, MD', 'role': 'CONTACT', 'email': 'wdrake@som.umaryland.edu'}], 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fabiola Gianella', 'role': 'CONTACT', 'email': 'Fabiola.Gianella@UTsouthwestern.edu', 'phone': '214-648-7875'}], 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Laura Koth', 'role': 'CONTACT', 'email': 'laura.koth@ucsf.edu', 'phone': '4155144369'}, {'name': 'Jessica Cardenas', 'role': 'CONTACT', 'email': 'jessica.cardenas@ucsf.edu'}], 'overallOfficials': [{'name': 'Laura Koth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, {'name': 'University of Texas, Southwestern Medical Center at Dallas', 'class': 'OTHER'}, {'name': 'Wayne State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}