PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

Melanoma Clinical Trial

— ANTIPRAME  

Official title:

PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05089188
• Other study ID #: 8420
• Status: Not yet recruiting
• Start date: November 2021
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 ...)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: November 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Immunomarkers
immunohistochemical expression profile of ambiguous melanocytic proliferation.

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunomarkers	Correlation of melanocytic lesions' histopathological diagnosis concerning benignity or malignancy with anti-PRAME immunohistochemical expression profile	1 month