A study of molecular markers and risk stratification in Indian women with endometrial cancer: An Ambispective study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1. Number and percentage of cases with positive molecular markers (PoleMutated, MLH1,
研究概览
简要总结
All consecutive biopsy-proven patients with endometrial cancer satisfying eligibility criteria from January 2018 to December 2025 at AIIMS Rishikesh will be included after explaining the objective, procedure, expected outcome, and possible side effects, if any. Written and informed consent will be taken from all prospective participants for the use of their medical records for research purposes. For retrospective cases, permission will be taken from the Medical Superintendent to retrieve data from our institutional database (patient’s clinical records and pathology reports).
Demographic characteristics, including body mass index (BMI), menopausal status, parity,
performance status, medical comorbidities, clinicopathological, radiological (CT/ MRI)
findings, surgical characteristics, and pathology-associated parameters, including histological
type, tumor grade, stage of the disease, myometrial invasion, lymph node spread,
lymphovascular space invasion, surgical margins, bilateral adnexa, or cervical stroma, will be
documented. All pathology slides will be reviewed by pathologists to confirm grade and
histotype. The stage will be determined according to the International Federation of
Gynecology and Obstetrics (FIGO) 2009 and the recent molecular classification of FIGO
Cinicopathological risk stratification will be done using the ESGO/ESMO/ESTRO consensus
Data will be analyzed for the adjuvant treatment received in the form of brachytherapy,
external beam radiotherapy, or chemoradiation. Recurrence pattern, 5-year disease-free
survival (only in cases managed till March 2021), and overall survival will be noted. Disease-specific survival will be calculated as the time from surgery to death from endometrial
cancer. The cause of death will be mainly based on medical records.
Other biomarkers such as L1CAM, ER, PR, and HER2 expression, CTNNB1, PTEN, E-cadherin, and ARID1A mutations will be studied, if feasible, and their association with
prognosis and clinicopathological data will be described.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histological diagnosis of endometrial cancer.
- •Execution of hysterectomy (with or without salpingo-oophorectomy) with or without nodal dissection
- •All stages of endometrial carcinoma (I-IV).
排除标准
- •Consent withdrawal
- •Patients with poor-quality slides/blocks (making pathological assessment difficult)
- •Poor quality of DNA obtained.
结局指标
主要结局
1. Number and percentage of cases with positive molecular markers (PoleMutated, MLH1,
时间窗: Baseline, 1 year, 3 year, 5 years
MSH2, MSH6, and PMS2, p53 abnormal).
时间窗: Baseline, 1 year, 3 year, 5 years
2. Risk stratification based on surgico-pathological risk groups and molecular findings (low,
时间窗: Baseline, 1 year, 3 year, 5 years
intermediate, high-intermediate, high, and advanced/metastatic) ESMO-ESGO-ESTRO
时间窗: Baseline, 1 year, 3 year, 5 years
2016 and ESGO-ESTRO-ESP 2020 risk group classification.
时间窗: Baseline, 1 year, 3 year, 5 years
3. The number of cases that were upstaged or downstaged as per FIGO staging 2009 and
时间窗: Baseline, 1 year, 3 year, 5 years
2023.
时间窗: Baseline, 1 year, 3 year, 5 years
次要结局
- 1. Number and percentage of cases who were multiple classifiers.(2. Involvement of myometrium, surgical margins, bilateral adnexa, cervical stroma,)
研究者
Kavita Khoiwal
AIIMS Rishikesh