Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-06 @ 4:45 PM
Study NCT ID:
NCT05986461
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spatially Transcriptomics Reveals Molecular Signatures in CRPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Punch biopsied skin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2023-08-03', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 'At the time of biopsy', 'description': 'Intensity of pain (now, weekly avarege, weekly maximum)'}, {'measure': 'Thermography', 'timeFrame': 'At the time of diagnosis', 'description': 'Thermography of the involved limb'}, {'measure': 'Quantitative Sensory Testing (QST)', 'timeFrame': 'At the time of diagnosis', 'description': 'Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complex Regional Pain Syndromes']}, 'referencesModule': {'references': [{'pmid': '34165690', 'type': 'RESULT', 'citation': 'Taylor SS, Noor N, Urits I, Paladini A, Sadhu MS, Gibb C, Carlson T, Myrcik D, Varrassi G, Viswanath O. Complex Regional Pain Syndrome: A Comprehensive Review. Pain Ther. 2021 Dec;10(2):875-892. doi: 10.1007/s40122-021-00279-4. Epub 2021 Jun 24.'}, {'pmid': '34381231', 'type': 'RESULT', 'citation': 'Rao A, Barkley D, Franca GS, Yanai I. Exploring tissue architecture using spatial transcriptomics. Nature. 2021 Aug;596(7871):211-220. doi: 10.1038/s41586-021-03634-9. Epub 2021 Aug 11.'}, {'pmid': '24462502', 'type': 'RESULT', 'citation': 'Birklein F, Drummond PD, Li W, Schlereth T, Albrecht N, Finch PM, Dawson LF, Clark JD, Kingery WS. Activation of cutaneous immune responses in complex regional pain syndrome. J Pain. 2014 May;15(5):485-95. doi: 10.1016/j.jpain.2014.01.490. Epub 2014 Jan 23.'}, {'pmid': '33892152', 'type': 'RESULT', 'citation': 'Escolano-Lozano F, Gries E, Schlereth T, Dimova V, Baka P, Vlckova E, Konig S, Birklein F. Local and Systemic Expression Pattern of MMP-2 and MMP-9 in Complex Regional Pain Syndrome. J Pain. 2021 Oct;22(10):1294-1302. doi: 10.1016/j.jpain.2021.04.002. Epub 2021 Apr 20.'}, {'pmid': '27365449', 'type': 'RESULT', 'citation': 'Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M, Mollbrink A, Linnarsson S, Codeluppi S, Borg A, Ponten F, Costea PI, Sahlen P, Mulder J, Bergmann O, Lundeberg J, Frisen J. Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403.'}, {'pmid': '32579974', 'type': 'RESULT', 'citation': 'Ji AL, Rubin AJ, Thrane K, Jiang S, Reynolds DL, Meyers RM, Guo MG, George BM, Mollbrink A, Bergenstrahle J, Larsson L, Bai Y, Zhu B, Bhaduri A, Meyers JM, Rovira-Clave X, Hollmig ST, Aasi SZ, Nolan GP, Lundeberg J, Khavari PA. Multimodal Analysis of Composition and Spatial Architecture in Human Squamous Cell Carcinoma. Cell. 2020 Jul 23;182(2):497-514.e22. doi: 10.1016/j.cell.2020.05.039. Epub 2020 Jun 23.'}, {'pmid': '34997300', 'type': 'RESULT', 'citation': 'Andronic D, Andronic O, Juengel A, Berli MC, Distler O, Brunner F. Skin biomarkers associated with complex regional pain syndrome (CRPS) Type I: a systematic review. Rheumatol Int. 2022 Jun;42(6):937-947. doi: 10.1007/s00296-021-05061-5. Epub 2022 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (CRPS).', 'detailedDescription': "Participants who meet the diagnostic criteria for CRPS, aged 19\\~80 years, and agree to participate in this study will undergo a 4mm-sized skin punch biopsy in the involved limb, as well as the contralateral side (internal control).\n\nSpatial transcriptomics will be used to identify immune cell signatures and differentially regulated genes (DEGs) in the epidermis, vasculature, sweat gland, and nerve plexus of the involved ipsilateral (vs contralateral) side of the patient's skin."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CRPS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets the Budapest diagnostic criteria\n* Consents to participation in this study\n* Aged between 19 and 80 years old\n* Symptoms and/or signs of sensory, vasomotor, and sudomotor changes\n\nExclusion Criteria:\n\n* Who do not agree to participate in this study\n* Who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking anticoagulant drugs)'}, 'identificationModule': {'nctId': 'NCT05986461', 'briefTitle': 'Spatially Transcriptomics Reveals Molecular Signatures in CRPS', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University'}, 'officialTitle': 'Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome', 'orgStudyIdInfo': {'id': '2304-052-1421'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jee Youn Moon, M.D.', 'role': 'CONTACT', 'email': 'jymoon0901@gmail.com', 'phone': '82-10-5299-2036'}, {'name': 'Jee Youn Moon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jee Youn Moon, MD, PhD', 'role': 'CONTACT', 'email': 'jymoon0901@gmail.com', 'phone': '82-10-5299-2036'}, {'name': 'Jeongsoo Kim, MD', 'role': 'CONTACT', 'email': 'dreamsu457@gmail.com', 'phone': '82-10-4734-6422'}], 'overallOfficials': [{'name': 'Jee Youn Moon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanyang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeeyoun Moon', 'investigatorAffiliation': 'Seoul National University'}}}}