Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-27 @ 4:41 AM
Study NCT ID:
NCT06264492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delving Into Participation Trends of Scleroderma Clinical Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-09', 'size': 71611, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-09T10:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients in clinical research for scleroderma', 'timeFrame': '3 months'}, {'measure': 'Number of scleroderma study participants who stay committed until clinical study wraps up', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['scleroderma'], 'conditions': ['Scleroderma']}, 'referencesModule': {'references': [{'pmid': '23791631', 'type': 'BACKGROUND', 'citation': 'Careta MF, Leite Cda C, Cresta F, Albino J, Tsunami M, Romiti R. Prospective study to evaluate the clinical and radiological outcome of patients with scleroderma of the face. Autoimmun Rev. 2013 Sep;12(11):1064-9. doi: 10.1016/j.autrev.2013.05.005. Epub 2013 Jun 19.'}, {'pmid': '33527717', 'type': 'BACKGROUND', 'citation': 'Harb S, Pelaez S, Carrier ME, Kwakkenbos L, Bartlett SJ, Hudson M, Mouthon L, Sauve M, Welling J, Shrier I, Thombs BD; SPIN Physical Activity Enhancement Patient Advisory Team and SPIN Investigators. Barriers and Facilitators to Physical Activity for People With Scleroderma: A Scleroderma Patient-Centered Intervention Network Cohort Study. Arthritis Care Res (Hoboken). 2022 Aug;74(8):1300-1310. doi: 10.1002/acr.24567. Epub 2022 May 11.'}, {'pmid': '35880663', 'type': 'BACKGROUND', 'citation': 'Li SC. Treatment of juvenile localized scleroderma: current recommendations, response factors, and potential alternative treatments. Curr Opin Rheumatol. 2022 Sep 1;34(5):245-254. doi: 10.1097/BOR.0000000000000886.'}]}, 'descriptionModule': {'briefSummary': 'Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.\n\nThe study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with scleroderma who are actively considering participation in a clinical trial for this ailment, but have not yet concluded the enrollment and randomization phases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been diagnosed with scleroderma\n* Patient has self-identified as planning to enroll in an observational clinical trial\n* Patient is a minimum of 18 years or older\n\nExclusion Criteria:\n\n* Patient is pregnant\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form'}, 'identificationModule': {'nctId': 'NCT06264492', 'briefTitle': 'Delving Into Participation Trends of Scleroderma Clinical Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Deciphering Patient Participation: Insights From Observational Data in Scleroderma Clinical Trials', 'orgStudyIdInfo': {'id': '55777205'}}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'https://www.withpower.com/contact-us@withpower.com', 'phone': '415-900-4227'}], 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '4159004227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}