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NCT02761473 · ClinicalTrials.gov registry record

Cutaneous Mastocytosis in Children: Analysis of Somatic and Germline Mutations

A clinical trial, sponsored by University of Minnesota.

Completed
Registry status
50
Enrollment target

NCT02761473: Completed study, sponsored by University of Minnesota.

NCT02761473 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02761473 has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
50 participants
Enrollment target

Study Summary

Pediatric mastocytosis is an orphan disease, which encompasses several clinically distinct entities including solitary mastocytoma, urticaria pigmentosa, diffuse cutaneous mastocytosis and the newly recognized mast cell activation syndrome. The most common form of pediatric mastocytosis is cutaneous maculopapular mastocytosis (CMPM), also known as urticaria pigmentosa (UP). There are significant knowledge gaps regarding the genetic basis of pediatric mastocytosis and the functional activity of mast cells in this condition. The Pediatric Dermatology and Pediatric Oncology services at the University of Minnesota Masonic Children's Hospital are seeing significant growth in clinical volumes of pediatric mastocytosis, including rare, familial cases. The aims of this study are to prospectively explore germline risk for UP and to perform a mutational analysis to identify somatic mutations, beyond those currently identified, in pediatric patients with UP.

Primary Outcome

Fresh tissue from lesional skin will be obtained for gene expression and mutational analysis

Interventions

  • OTHER blood draw
  • OTHER skin biopsy

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2016-11
Est. Completion 2020-05-01
University of Minnesota

966 total trials

What the finished NCT02761473 record still lists

NCT02761473 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which blood draw is the first listed.

NCT02761473 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02761473 about?

NCT02761473 is a clinical study titled "Cutaneous Mastocytosis in Children: Analysis of Somatic and Germline Mutations". Pediatric mastocytosis is an orphan disease, which encompasses several clinically distinct entities including solitary mastocytoma, urticaria pigmentosa, diffuse cutaneous mastocytosis and the newly recognized mast cell activation syndrome. The most common form of pediatric mastocytosis is cutaneous...

What is the current status of trial NCT02761473?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2016-11. Estimated completion is 2020-05-01.

What interventions are being tested in trial NCT02761473?

The interventions under investigation include: blood draw (OTHER), skin biopsy (OTHER).

Who is sponsoring clinical trial NCT02761473?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02761473, the US trial registry maintained by the National Library of Medicine. NCT02761473 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.