Impact of Molecular Pathological And Clinical Features for Adjuvant Treatment Selection in Endometrial Cancer: Asian Registry

NCT07354087 | Active Not Recruiting DMC

• 1 other identifier: TMC IEC No 4453
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

The treatment practices for endometrial cancer have significantly changed over the last two decades. Nowadays, in addition to standard pathology, additional tests are performed to understand the behaviour of tumour so that personalized treatment can be advised for every patient. This approach ensures that patients with good cancer cell features receive minimum essential radiotherapy or surgery treatment with fewer side effects, while those with poor cell features undergo more aggressive treatment to improve their chances of survival. However, this approach is not widely adopted in Asian countries. To address this, investigators are launching a project to gather data from various hospitals across Asia. The project aims to understand how different cancer cell factors impact treatment decisions and identify better ways to select additional treatment plans based on a patient's cancer cell features. The project will gather data from around 250-300 patients who were evaluated or treated between January 2021 and December 2023. It will run for two years to improve our understanding and gain insights into the best ways to treat endometrial cancer.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (4)

• To study the Clinico-pathological characteristics in Endometrial Cancer

  Proportion of Endometrial Cancer Molecular Subtypes (POLEmut, MMR-deficient, NSMP, p53 abnormal) and distribution of adjuvant radiation therapy types received (vaginal brachytherapy, external beam radiation therapy \[EBRT\], or combined radiation with chemotherapy) reported at treatment completion.

  24 months

• To study molecular characteristics in Endometrial Cancer.

  Proportion of Endometrial Cancer Cases by Tumor Grade, Histological Type, and Tumor Stage

  24 Months

• To study the Clinicopathologic characteristics impact on treatment decision making across Asian regions

  proportion of patients who exhibit predefined clinicopathologic characteristics with percentages reported for each participating Asian region

  24 Months

• To study molecular characteristics impact on treatment decision making across Asian regions.

  Proportion of participants whose treatment decisions are influenced by molecular characteristics. Data will be summarized by Asian region and analyzed in relation to clinical and demographic characteristics to assess the overall impact on treatment decision making.

  24 Months

Secondary Outcomes (8)

• Comparison of risk grouping using standard histopathological features versus standard histopathological features plus molecular profile

  24 Months

• To report the selection of adjuvant treatment based on standard histopathological features alone or along with molecular risk features

  24 Months

• To study the transition of staging towards FIGO 2023.

  24 Months

• To study the adequacy of risk grouping practices across Asian regions by comparing to ESTRO/ESGO/ESP and FIGO updates

  24 Months

• To study the choice of External beam radiotherapy technique and brachytherapy applicators utilized

  24 Months

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to include all patients with histological proven Endometrial Cancer from participating Institutes fulfilling the study criteria. This will allow better understanding of standard histopathological reporting and its impact on adjuvant treatment decisions.

You may qualify if:

• \- Patients who were diagnosed to have EC and have access to standard histopathological reports and availability of treatment decisions.

You may not qualify if:

• \- Patients with final histopathological diagnosis of any other gynecological malignancy other than EC and its subtypes.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (2)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Supriya Sastri (Chopra), MD, DNB

  ACTREC, Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiation Oncology

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 21, 2026
• Study Start: November 28, 2024
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 27, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)