Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus (PANGEA)

Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus (PANGEA Study) : A National Qualitative Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Psychology, Social; Parent; Congenital Melanocytic Nevus; Congenital Melanocytic Nevi
• Intervention / Treatment: Other: No Intervention: Observational Cohort

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• France
  • France
    • Nancy, France, France, 54035
      • Centre Hospitalier Régional Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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, Grenoble and Saint Pierre.

Description

Inclusion Criteria:

• Aged 18 years or older
• Willing to participate in a semi-structured interview
• Has received full information about the research and has not objected to participating or to the use of their data
• Able to understand and speak French
• Parent of a child under 18 years of age

Exclusion Criteria:

• Under 18 years of age
• Not willing to participate
• Currently under legal protection (e.g., guardianship or curatorship)
• Cognitive and/or psychological impairments preventing participation in a semi-structured interview
• Poor understanding and/or expression of the French language
• Parent of a child over 18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with congenital melanocytic nevus	Other: No Intervention: Observational Cohort; There is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of the Semi-Structured Interviews with Parents	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 hour. 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. The 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	Socio-demographic data and interview transcripts will be collected during the semi-structured interviews (lasting between 30 minutes and 1 hour), thus at a single time point (Day 1). No follow-up is required.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Assistance Publique Hopitaux De Marseille; Centre Hospitalier Universitaire Dijon; Centre Hospitalier Universitaire de la Réunion; Centre Hospitalier Universitaire de Nice; University Hospital, Brest; University Hospital, Grenoble; Nantes University Hospital; Hôpital Necker-Enfants Malades; Annecy Hospital, France

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: psychology; parents; congenital melanocytic nevus; congenital melanocytic nevi; lived experience
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Nevi and Melanomas; Nevus, Spindle Cell; Nevus; Nevus, Pigmented; Nevus, Epithelioid and Spindle Cell
• Other Study ID Numbers: 2024PI238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No