PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

NCT05089188 | Unknown

• 1 other identifier: 8420
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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 ...)

Conditions

Melanoma

Keywords

Immunohistochemistry; Histopathology

Outcome Measures

Primary Outcomes (1)

• Immunomarkers

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

  1 month

Interventions

Immunomarkers OTHER

immunohistochemical expression profile of ambiguous melanocytic proliferation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

FR (1)