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Status unknownNCT05089188ANTIPRAMEUpdated Oct 22, 2021

PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

An observational study in Melanoma, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
55
Ages
18 Years and older
Sex
All
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Study summary

Skin melanoma is a common form of skin cancer. Its diagnosis is usually clinically suspected and then affirmed by histopathological examination.

In some cases, the histopathological analysis of these lesions is equivocal, and the malignant or benign nature of the proliferation is difficult to determine with certainty. In these cases, the use of expensive ancillary tests, which are hardly accessible and take a long time to set up (FISH - CGH-array), is usually required.

Anti-PRAME immunostaining, an inexpensive and readily available technic, has recently been described as highly sensitive and specific for diagnosing malignant melanocytic proliferations. Knowledge on its utility for evaluating ambiguous melanocytic neoplasms remains limited.

Our study aims to improve the current body of knowledge on the utility of PRAME immunohistochemistry for evaluating challenging samples of melanocytic proliferation. The secondary objective is to determine the PRAME immunoreactivity profile for each histological subtype of melanocytic proliferations (spitzoid tumors, cellular blue nevi, dysplastic nevi ...)

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Conditions studied

  • Melanoma

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Keywords

  • Immunohistochemistry
  • Histopathology
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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 55 is below the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All cases with histopathological diagnosis of "ambiguous melanocytic proliferation" or "atypical melanocytic proliferation" made between January 2016 and December 2020.

Inclusion criteria

  • Adult patient at the time of diagnosis (> = 18 years).
  • histopathological diagnosis of "ambiguous melanocytic proliferation" or "atypical melanocytic proliferation" made between January 2016 and December 2020.
  • Histological slides archived in the "CRB" biobank available
  • Formalin-fixed paraffin-embedded tissue block archived in the "CRB" biobank available
  • Informed patient

Exclusion criteria

Exclusion Criteria:

  • Patient who has expressed opposition to participating in the study.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
55 participants (estimated)
Patient registry
No

Interventions

  • OtherImmunomarkers

    immunohistochemical expression profile of ambiguous melanocytic proliferation.

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What researchers measure

Primary outcomes

  1. Immunomarkers

    Correlation of melanocytic lesions' histopathological diagnosis concerning benignity or malignancy with anti-PRAME immunohistochemical expression profile

    Time frame: 1 month

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Study locations

1 site
  • Les Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05089188
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Oct 22, 2021
Start date
Nov 2021 (estimated)
Primary completion
Nov 2021 (estimated)
Completion
Nov 2022 (estimated)
Last update
Oct 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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