PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

NCT ID: NCT05089188

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-11-30

Brief Summary

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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 ...)

Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Immunomarkers

immunohistochemical expression profile of ambiguous melanocytic proliferation.

Intervention Type OTHER

Eligibility Criteria

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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

* Patient who has expressed opposition to participating in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Facility Contacts

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Mona MITCOV

Role: primary

+33 3 88 11 73 77

Other Identifiers

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8420

Identifier Type: -

Identifier Source: org_study_id