ClinicalTrials.gov record NCT06330350
Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling
Investigating Perspectives of Patients With Genodermatosis and Healthcare Professionals on Reproductive Counselling
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a qualitative observational study using semi-structured interviews. It seeks the views of adult patients with genodermatoses who want children (and, if applicable, their partners) and of healthcare professionals involved in their care. The interviews will explore decisions and knowledge about reproductive options.
What it is studying. The study aims to learn how patients with genodermatoses, their partners, and clinicians think about reproductive choices and counselling. It will assess perspectives and the level of knowledge about options such as prenatal diagnosis, pre-implantation genetic testing, adoption, donor gametes, choosing not to have children, natural pregnancy without genetic testing, and foster care.
What the researchers hope to learn. To describe the needs, perspectives, and knowledge gaps around reproductive decision-making in people with genodermatoses and among clinicians. Findings are intended to inform future research and guidance on reproductive counselling for these conditions.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Qualitative interview
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Adult patients with genodermatosis (i.e, keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) and a desire to have children, with if applicable his or her partner with a desire to have children
- Patients with clinically and molecularly confirmed variant of a genodermatosis
- Health care professionals involved with the care of genodermatology patients (e.g. clinical geneticists, dermatologists)
Exclusion criteria
- Not being able to communicate verbally in Dutch or English
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants take part in an individual semi-structured qualitative interview. Interviews will ask about reproductive decision-making and knowledge of options (for example prenatal diagnosis, pre‑implantation genetic testing, donor gametes, adoption, refraining from having children, natural pregnancy without genetic testing, or foster care). The registry lists interviews as the study activity and does not specify other tests, invasive procedures, or sample collection.
How the study is structured. A prospective qualitative study. Participants take part in individual semi-structured interviews (patients, partners where relevant, and healthcare professionals). There is no treatment assignment; the study records and analyzes participants' experiences and views.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Netherlands. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Jan 1, 2024
- Primary completion
- Aug 31, 2025 (estimated)
- Study completion
- Dec 31, 2025 (estimated)
- Target enrollment
- 25 participants (estimated)
- Last updated on registry
- May 18, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Maastricht University Medical Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Fauve C van Veen, MD 📞 +31433877293 ✉ genodermatose@mumc.nl
Participating sites (1)
- Maastricht University Medical CenterRecruiting
Maastricht, Limburg, 6202 AZ · Netherlands
- Fauve C van Veen · +31433877293 · genodermatose@mumc.nl
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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