Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 4:19 PM
Study NCT ID:
NCT05560906
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2022-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000705967', 'term': 'pediatric multisystem inflammatory disease, COVID-19 related'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripherial blood mononuclear cell samples Whole blood samples Leukocytes obtained during nasal mucosa curettage'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in leukocyte subpopulations in nasal mucosa and peripherial blood during MIS-C and convalescence.', 'timeFrame': 'Three clinical timepoints: (i) baseline (preferably before immunomodulatory treatment), (ii) convalescence, after major symptoms resolution (1 week +/-2 days after treatment introduction), (iii) outpatient control visit (6 weeks after hospital discharge)', 'description': 'The cellular subpopulations will be characterized and clustered using prepared immunomarker array.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leukocytes', 'immunophenotype', 'nasal mucosa', 'curettage'], 'conditions': ['MIS-C Associated With COVID-19', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '32891582', 'type': 'BACKGROUND', 'citation': 'Radia T, Williams N, Agrawal P, Harman K, Weale J, Cook J, Gupta A. Multi-system inflammatory syndrome in children & adolescents (MIS-C): A systematic review of clinical features and presentation. Paediatr Respir Rev. 2021 Jun;38:51-57. doi: 10.1016/j.prrv.2020.08.001. Epub 2020 Aug 11.'}, {'pmid': '34356552', 'type': 'BACKGROUND', 'citation': 'Pawar R, Gavade V, Patil N, Mali V, Girwalkar A, Tarkasband V, Loya S, Chavan A, Nanivadekar N, Shinde R, Patil U, Lakshminrusimha S. Neonatal Multisystem Inflammatory Syndrome (MIS-N) Associated with Prenatal Maternal SARS-CoV-2: A Case Series. Children (Basel). 2021 Jul 2;8(7):572. doi: 10.3390/children8070572.'}, {'pmid': '32511692', 'type': 'BACKGROUND', 'citation': 'Whittaker E, Bamford A, Kenny J, Kaforou M, Jones CE, Shah P, Ramnarayan P, Fraisse A, Miller O, Davies P, Kucera F, Brierley J, McDougall M, Carter M, Tremoulet A, Shimizu C, Herberg J, Burns JC, Lyall H, Levin M; PIMS-TS Study Group and EUCLIDS and PERFORM Consortia. Clinical Characteristics of 58 Children With a Pediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-CoV-2. JAMA. 2020 Jul 21;324(3):259-269. doi: 10.1001/jama.2020.10369.'}, {'pmid': '32410760', 'type': 'BACKGROUND', 'citation': "Verdoni L, Mazza A, Gervasoni A, Martelli L, Ruggeri M, Ciuffreda M, Bonanomi E, D'Antiga L. An outbreak of severe Kawasaki-like disease at the Italian epicentre of the SARS-CoV-2 epidemic: an observational cohort study. Lancet. 2020 Jun 6;395(10239):1771-1778. doi: 10.1016/S0140-6736(20)31103-X. Epub 2020 May 13."}, {'pmid': '32790663', 'type': 'BACKGROUND', 'citation': 'Godfred-Cato S, Bryant B, Leung J, Oster ME, Conklin L, Abrams J, Roguski K, Wallace B, Prezzato E, Koumans EH, Lee EH, Geevarughese A, Lash MK, Reilly KH, Pulver WP, Thomas D, Feder KA, Hsu KK, Plipat N, Richardson G, Reid H, Lim S, Schmitz A, Pierce T, Hrapcak S, Datta D, Morris SB, Clarke K, Belay E; California MIS-C Response Team. COVID-19-Associated Multisystem Inflammatory Syndrome in Children - United States, March-July 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1074-1080. doi: 10.15585/mmwr.mm6932e2.'}, {'pmid': '32956615', 'type': 'BACKGROUND', 'citation': 'Harwood R, Allin B, Jones CE, Whittaker E, Ramnarayan P, Ramanan AV, Kaleem M, Tulloh R, Peters MJ, Almond S, Davis PJ, Levin M, Tometzki A, Faust SN, Knight M, Kenny S; PIMS-TS National Consensus Management Study Group. A national consensus management pathway for paediatric inflammatory multisystem syndrome temporally associated with COVID-19 (PIMS-TS): results of a national Delphi process. Lancet Child Adolesc Health. 2021 Feb;5(2):133-141. doi: 10.1016/S2352-4642(20)30304-7. Epub 2020 Sep 18.'}, {'pmid': '32991843', 'type': 'BACKGROUND', 'citation': "Gruber CN, Patel RS, Trachtman R, Lepow L, Amanat F, Krammer F, Wilson KM, Onel K, Geanon D, Tuballes K, Patel M, Mouskas K, O'Donnell T, Merritt E, Simons NW, Barcessat V, Del Valle DM, Udondem S, Kang G, Gangadharan S, Ofori-Amanfo G, Laserson U, Rahman A, Kim-Schulze S, Charney AW, Gnjatic S, Gelb BD, Merad M, Bogunovic D. Mapping Systemic Inflammation and Antibody Responses in Multisystem Inflammatory Syndrome in Children (MIS-C). Cell. 2020 Nov 12;183(4):982-995.e14. doi: 10.1016/j.cell.2020.09.034. Epub 2020 Sep 14."}, {'pmid': '34331778', 'type': 'BACKGROUND', 'citation': 'Okarska-Napierala M, Mandziuk J, Feleszko W, Stelmaszczyk-Emmel A, Panczyk M, Demkow U, Kuchar E. Recurrent assessment of lymphocyte subsets in 32 patients with multisystem inflammatory syndrome in children (MIS-C). Pediatr Allergy Immunol. 2021 Nov;32(8):1857-1865. doi: 10.1111/pai.13611. Epub 2021 Aug 11.'}, {'pmid': '34937933', 'type': 'BACKGROUND', 'citation': 'Roukens AHE, Pothast CR, Konig M, Huisman W, Dalebout T, Tak T, Azimi S, Kruize Y, Hagedoorn RS, Zlei M, Staal FJT, de Bie FJ, van Dongen JJM, Arbous SM, Zhang JLH, Verheij M, Prins C, van der Does AM, Hiemstra PS, de Vries JJC, Janse JJ, Roestenberg M, Myeni SK, Kikkert M, Yazdanbakhsh M, Heemskerk MHM, Smits HH, Jochems SP; in collaboration with BEAT-COVID group; in collaboration with COVID-19 LUMC group. Prolonged activation of nasal immune cell populations and development of tissue-resident SARS-CoV-2-specific CD8+ T cell responses following COVID-19. Nat Immunol. 2022 Jan;23(1):23-32. doi: 10.1038/s41590-021-01095-w. Epub 2021 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to make an accurate assessment of immune cells obtained from nasal mucosa and peripherial blood of MIS-C patients during the disease and the period of health.', 'detailedDescription': 'The study will consist of two parts. Initially, it will be of a cross-cutting comparative nature, when a group of healthy patients (control group) and a group of patients diagnosed with MIS-C/PIMS syndrome are compared with each other, based on nasal curettage swabs and peripheral blood, before the inclusion of systemic anti-inflammatory treatment (study group). In addition, an observation of the research group will be carried out, during which swabs and peripheral blood will be taken at two more control points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute MIS-C patients who have not received any treatment that could have altered nasal mucosa leukocyte composition. Samples will be collected from them at three time points.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MIS-C diagnosis based of WHO diagnostic criteria.\n\nExclusion Criteria:\n\n* immunosuppressive treatment received up to 3 months before\n* intranasal drugs received up to 7 days before\n* COVID-19 vaccination\n* no consent'}, 'identificationModule': {'nctId': 'NCT05560906', 'briefTitle': 'Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Study of Virus-specific Lymphocytic Cell Populations in Non-invasive Nasal Mucosa Samples of MIS-C Patients, and Intra-population Shifts in Inflammatory Tissues in the Acute Phase of MIS-C and in Health', 'orgStudyIdInfo': {'id': 'NAWA015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Healthy patients under 18 years of age.'}, {'label': 'MIS-C group', 'description': 'Patients with MIS-C diagnosed, based on WHO diagnostic criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-091', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Ziemowit Strzelczyk', 'role': 'CONTACT', 'email': 'ziemekstrzelczyk@gmail.com', 'phone': '505545747', 'phoneExt': '+48'}], 'facility': 'Pediatric teaching clinical hospital, Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Wojciech Feleszko, MD., PhD', 'role': 'CONTACT', 'email': 'wojciech.feleszko@wum.edu.pl', 'phone': '693468074', 'phoneExt': '+48'}, {'name': 'Ziemowit Strzelczyk', 'role': 'CONTACT', 'email': 'ziemekstrzelczyk@gmail.com', 'phone': '505545747', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Wojciech Feleszko, MD., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'After study patient data is processed.', 'ipdSharing': 'YES', 'description': "Clinical data of study patients could be shared upon other researchers' request.", 'accessCriteria': "Upon researcher's personal request."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Leiden University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD., PhD', 'investigatorFullName': 'Wojciech Feleszko', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}