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Clinical Trials/NCT06550674
NCT06550674
Active, not recruiting
Not Applicable

Identification of New Candidate Genes for Hereditary Predisposition to Uveal Melanoma

Centre Jean Perrin1 site in 1 country50 target enrollmentOctober 29, 2024
ConditionsUveal Melanoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uveal Melanoma
Sponsor
Centre Jean Perrin
Enrollment
50
Locations
1
Primary Endpoint
Identify new candidate genes for hereditary cancer predisposition in patients with uveal melanoma by constitutional exome analysis
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

Only 20% of familial uveal melanomas are explained by a hereditary predisposition, implying the presence of as yet unknown hereditary predispositions. This hypothesis is reinforced by epidemiological studies revealing an excess risk of prostate cancer, thyroid cancer and leukemia in patients who have developed uveal melanoma, even though these cancers are not part of the tumor spectrum of known hereditary predispositions to uveal melanoma (BAP1, MBD4). The identification of new candidate genes, once validated, would enable us to offer these families appropriate surveillance.

Registry
clinicaltrials.gov
Start Date
October 29, 2024
End Date
October 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Jean Perrin
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient with a personal history of uveal melanoma (newly diagnosed, under treatment or in follow-up)
  • Enrolled in or benefiting from a social security scheme

Exclusion Criteria

  • Causal pathogenic variation identified in BAP1 or MBD4
  • Patient does not consent to constitutional genetic analysis for diagnostic purposes
  • Patient not consenting to a constitutional genetic analysis for research purposes
  • Pregnant and breast-feeding women
  • Patients under guardianship or trusteeship

Outcomes

Primary Outcomes

Identify new candidate genes for hereditary cancer predisposition in patients with uveal melanoma by constitutional exome analysis

Time Frame: At baseline

Variants of interest are selected from the data using the following filter: * Variant with frequency \< 1% (GnomAD) * Shared by at least 2 sufferers in the cohort * Truncating (nonsense, with frame shift, on a canonical splice site -2, -1 and +1 +2) * Missense from a list of "cancer" genes and Combined Annotation Dependent Depletion (CADD) score \> 20 (COSMIC Tier1 and Tier2) Variants will be interpreted using various databases and prediction tools: * Functions: genecards, pubmed, uniprot * Expression profiles: cbioportal, GEPIA * For splice variants: CADD, Splice AI * For exonic variants: CADD, SIFT, Polyphene

Secondary Outcomes

  • Explore genes known to be involved in other cancer predisposition already described in the occurrence of uveal melanoma, but whose association has not yet been established with certainty.(At baseline)

Study Sites (1)

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