Prevalence of Germline Alterations in Actionable Genes in Endometrial Cancer

Sponsor
European Institute of Oncology
Study ID
NCT07066969
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sophia DDM — GENETIC
    Germline panel for patients with tumoral BRCA alteration in EC

Study Details

Endometrial cancer (EC) is the most common gynecological cancer in developed countries, with 10200 new cases of EC (5.5% of all cancers) estimated in 2023 and 2500 death for EC estimated in 2022 in Italy. Recently, the classical clinicopathological risk factors, such as age, FIGO stage, myometrial invasion, tumor grade, lymphovascular space invasion, and lymph node status, have been associated with molecular features for EC risk stratification. The recently introduced molecular classification, based on a very relevant publication of the "Integrated genomic characterization of endometrial carcinoma" by The Cancer Genome Atlas research network in 2013,2 requires the evaluation of three surrogate molecular markers, namely POLE sequencing, p53 immunohistochemical (IHC) evaluation, and mismatch repair (MMR) protein IHC evaluation, in order to reproduce the TCGA model and translate it into clinical practice. This molecular-based risk stratification provides a more accurate prediction of recurrent or metastatic disease than traditional clinicopathological criteria; however, more molecular knowledge is needed to better understand EC. Recently, the European Institute of Oncology implemented a new molecular panel for somatic evaluation of EC (Sophia DDM). The panel includes 54 genes, including BRCA1 and BRCA2.

Key Dates

First listed
Jul 15, 2025
Start date
Jan 22, 2026
Status verified
Jun 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Endometrial Cancer patients with tumoral BRCA
    Patients with diagnosis of endometrial cancer

Primary Outcome Measure

Frequency of actionable germline alterations in tBRCA mutated endometrial cancer. [ Time Frame: 18 months ]

Central Contacts

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Endometrial cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials

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