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

This trial does not accept healthy volunteers

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 population

Patients of Hospital Italiano de Buenos Aires. Section of Pathological Anatomy, Sequencing and Gynecological Oncology, and the "Norberto Quirno" Center for Medical Education and Clinical Research (CEMIC). Service of Pathological Anatomy, Molecular Pathology, Gynecology, Institute of Oncology, and Institute of Precision Medicine.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Distribution of Endometrial Cancer Molecular Subtypes Identified by Immunohistochemistry and POLE Sequencing

Proportion of patients in each of the four molecular subtypes of endometrial cancer (POLE-ultramutated, microsatellite instability hypermutated, copy-number low, copy-number high) determined using immunohistochemistry for MMR proteins and TP53, and NGS-based sequencing of the POLE gene.

Time frame
At study inclusion (retrospective evaluation of cases from the last 5 years). Units: Percentage of patients per subtype

Secondary outcomes

1

Association Between Molecular Subtypes and Histological Risk Categories.

Proportion of patients with low- versus high-risk histological types within each molecular subtype.

Time frame
At study inclusion (retrospective evaluation of cases from the last 5 years).
2

Time to Recurrence by Molecular Subtype

Time (in months) from diagnosis to first documented relapse, stratified by molecular subtype.

Time frame
At study inclusion (retrospective evaluation of cases from the last 5 years).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Hospital Italiano de Buenos Aires

Lead sponsor

CEMIC Buenos Aires

Collaborator

This trial is not recruiting at the moment. You can still explore other options: