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A Cohort Study of Giant Congenital Melanocytic Nevi

A Rare Disease Cohort Study of Giant Congenital Melanocytic Nevi

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126114
Enrollment
Unknown
Registered
2026-06-03
Start date
2026-06-03
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital giant naevus

Interventions

Case group:NA

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1.Presence of extensive black discoloration of the skin on the body surface detected since birth, with the largest lesion referred to as the "primary nevus." According to the internationally accepted Krengel classification (Table 2), a diagnosis of large/giant congenital melanocytic nevus (LGCMN) is established when the projected adult size (PAS) of the primary nevus is > 20 cm. 2.Age: 3 months to 60 years. Sex: both males and females. 3.The patient voluntarily participates in this cohort study and provides written informed consent. 4.The patient agrees to provide tissue specimens and peripheral blood for the investigation of genetic correlations and relevant factors underlying the pathogenesis of giant congenital melanocytic nevi. 5.The participant is able to comply with the study procedures and follow-up assessments as required by the protocol.

Exclusion criteria

Exclusion criteria: 1.Poor compliance, or judged by the investigator to be unsuitable for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
Disease progression rate of giant congenital melanocytic nevi, calculated based on pathological examinations, dermatological assessments, and imaging findings.;

Secondary

MeasureTime frame
Changes in plasma cytokine;Evaluation of recurrence of the giant congenital melanocytic nevus lesion.;Evaluation of the natural history of the disease;Changes in clinical manifestations;The proportion of patients with giant congenital melanocytic nevi achieving stable disease or regression;

Countries

China

Contacts

Public ContactLi Qingfeng

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

dr.liqingfeng@shsmu.edu.cn+86 21 53315120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026