Precision Medicine Applied to the Study of Endometrial Cancer: Application of NGS for Molecular Classification

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHospital Italiano de Buenos Aires

About this trial

In recent years, knowledge about cancer biology has expanded significantly. The study of gene expression profiles has revealed the heterogeneous nature and potential reclassification of the various tumor subtypes based on specific genetic alterations. This is of great importance since it allows a therapeutic approach more directed to the intrinsic characteristics of each tumor (precision medicine).

Integrating clinicopathological information with molecular classification could provide new guidelines when approaching patients with EC, both in preoperative assessment and in adjuvant treatment and surveillance.

The application of molecular classification in endometrial carcinomas shows a subgroup of patients with an excellent prognosis, corresponding to the POLEmut subgroup that could be reclassified with eventual therapeutic de-escalation.

The clinical guidelines for the management of patients with endometrial cancer proposed by ESGO/ESTRO/ESP in 2020 recommend the use of this new classification, and warn that clinical management may be modified by the molecular classification in scenarios where adjuvant chemotherapy is considered (high-grade/high-risk disease).

Eligibility criteria

Qualifiers

Patients over 18 years of age with a diagnosis of EC diagnosed by histological biopsy and surgically treated sequentially in the participating centers in the last 5 years with clinical follow-up.

Patients over 18 years of age, diagnosed with CE III-IV by histological biopsy, not susceptible to surgical treatment in each institution during the last 5 years in clinical follow-up. Cases with a diagnosis of carcinosarcoma (a rare subtype of endometrial carcinoma with sarcomatous transdifferentiation) are included.

Material blocks fixed in formalin and embedded in paraffin with a tumor volume in the paraffin block of at least 1 cm3

Disqualifiers

Biphasic tumors (epithelial-mesenchymal) such as adenosarcoma.

Mesenchymal neoplasms such as endometrial stromal sarcoma and leiomyosarcomas.

Others: primary lymphoproliferative processes of the uterine body; neuroendocrine tumors; Gestational trophoblastic disease, secondary lesions either of the genital tract (example: cervical carcinomas with extension to the endometrium) or of distant sites (breast cancer metastasis).

Patients with synchronous endometrial and ovarian carcinoma

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

This trial has no locations

Sponsors and collaborators

Hospital Italiano de Buenos Aires

Lead sponsor

CEMIC Buenos Aires

Collaborator