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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05089188
Other study ID # 8420
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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