Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-07 @ 10:15 AM
Study NCT ID:
NCT06934759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-12', 'studyFirstSubmitDate': '2025-04-06', 'studyFirstSubmitQcDate': '2025-04-12', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of the Semi-Structured Interviews with Parents', 'timeFrame': 'Socio-demographic data and interview transcripts will be collected during the semi-structured interviews (lasting between 30 minutes and 1.5 hours), thus at a single time point (Day 1). No follow-up is required.', 'description': 'Analysis of the interview transcripts = verbatim analysis Individual semi-structured interviews will be conducted via videoconference, with an estimated duration of 30 minutes to 1.5 hours. An interview guide has been developed to define the key dimensions to be explored. Each interview will be audio-recorded using a voice recorder and then fully transcribed.\n\nThe interviews will undergo a thematic content analysis to identify meaningful patterns ("nodes of meaning") within participants\' narratives, using an inductive approach. A double coding will be performed by two investigators on five interviews to strengthen the thematic framework. The remaining interviews will be coded by a single investigator'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parents', 'congenital melanocytic nevus', 'congenital melanocytic nevi', 'psychology', 'lived experience'], 'conditions': ['Congenital Melanocytic Nevi', 'Congenital Melanocytic Nevus', 'Parent', 'Psychology, Social']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to describe the experiences of parents at the birth of a child with a large or giant congenital melanocytic nevus through semi-structured interviews, and to identify potential intervention strategies to improve their care and support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will include parents of children with a large or giant congenital melanocytic nevus who are being followed at the university hospitals (CHRU) of Nancy, Marseille, Nantes, Dijon, Necker, Nice, Brest, Annecy, and Toulouse.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Willing to participate in a semi-structured interview\n* Has received full information about the research and has not objected to participating or to the use of their data\n* Able to understand and speak French\n* Parent of a child under 18 years of age\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Not willing to participate\n* Currently under legal protection (e.g., guardianship or curatorship)\n* Cognitive and/or psychological impairments preventing participation in a semi-structured interview\n* Poor understanding and/or expression of the French language\n* Parent of a child over 18 years of age'}, 'identificationModule': {'nctId': 'NCT06934759', 'acronym': 'PAGIAN', 'briefTitle': 'Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus: A National Qualitative Study', 'orgStudyIdInfo': {'id': '2024PI238'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with congenital melanocytic nevus', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'There is no intervention', 'armGroupLabels': ['Children with congenital melanocytic nevus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54035', 'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'Anne-Claire BURSZTEJN, Professor', 'role': 'CONTACT', 'email': 'ac.bursztejn@chru-nancy.fr', 'phone': '+33383157146'}, {'name': 'Camille LAHET, Resident', 'role': 'CONTACT', 'email': 'cami.lahet@gmail.com', 'phone': '+33618436507'}], 'facility': 'Centre Hospitalier Régional Universitaire de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Anne-Claire BURSZTEJN, Professor', 'role': 'CONTACT', 'email': 'ac.bursztejn@chru-nancy.fr', 'phone': '+33383157146'}, {'name': 'Camille LAHET, Resident', 'role': 'CONTACT', 'email': 'cami.lahet@gmail.com', 'phone': '+33618436507'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor and Principal Investigator', 'investigatorFullName': 'Anne Claire BURSZTEJN', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}