Congenital Melanocytic NeviPANGEANCT06934759
Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus
An observational study of Congenital Melanocytic Nevi and Congenital Melanocytic Nevus, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Melanocytic Nevi, Congenital Melanocytic Nevus, Parent
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to 31 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Régional Universitaire de Nancy
Nancy, France, 54035
About this study
Official title: 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.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- parents, congenital melanocytic nevus, congenital melanocytic nevi, psychology, lived experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| Children with congenital melanocytic nevus | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Melanocytic NeviStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, Hôpital Necker-Enfants Malades, Centre Hospitalier Universitaire de Nice, University Hospital, Brest, Annecy Hospital, France, Centre Hospitalier Universitaire Dijon, Nantes University Hospital, University Hospital, Grenoble, Centre Hospitalier Universitaire de la Réunion
- Responsible party
- Principal investigator, Anne Claire BURSZTEJN, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934759
- Sponsor's protocol ID
- 2024PI238
- Acronym
- PANGEA
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus (PANGEA Study) : A National Qualitative Study
- ClinicalTrials.gov ID
- NCT06934759
- Acronym / sponsor ID
- PANGEA / 2024PI238
- Keywords
- parents, congenital melanocytic nevus, congenital melanocytic nevi, psychology, lived experience
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, Hôpital Necker-Enfants Malades, Centre Hospitalier Universitaire de Nice, University Hospital, Brest, Annecy Hospital, France, Centre Hospitalier Universitaire Dijon, Nantes University Hospital, University Hospital, Grenoble, Centre Hospitalier Universitaire de la Réunion
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with congenital melanocytic nevus | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThere is no intervention | Other | Children with congenital melanocytic nevus |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Melanocytic Nevi and Congenital Melanocytic Nevus, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.