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Enrolling by Invitation

NCT Number: NCT06934759

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Régional Universitaire de Nancy

Nancy, France, 54035

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

There is no intervention

Primary outcomes

  1. Results of the Semi-Structured Interviews with Parents

    Time frame: 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.

    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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PANGEA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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