A Single-Center Observational Study Comparing 2023 FIGO Staging with 2009 FIGO Staging in Endometrial Cancer Patients: Implications for Treatment Planning and the Role of Molecular Testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 7
- 主要终点
- To evaluate the stage migration in patients with endometrial cancer staged with FIGO 2009 to FIGO 2023 staging system and the outcomes of patients staged with FIGO 2023 staging system.
研究概览
简要总结
Endometrial carcinoma is the 6th most common cancer among women(1). In non-metastatic endometrial carcinoma, primary treatment is surgery. Following surgery, based on histopathological features, staging is done using International Federation of Gynaecology and Obstetrics (FIGO) system. FIGO 2009 system was been used for staging and in 2023, FIGO updated their staging system in 2023, which incorporated both histopathological and molecular features(2).Using the new FIGO system, there is stage migration, which leads to upstaging of disease which were previously low risk. But there is a lot of confusion on how to manage and incorporate the current staging into clinical practise and there is very little real world evidence from India. This study aims to fulfil the feasibility of using the new FIGO staging along with the molecular classification and see how it affects the treatment plans of patients with non-metastatic carcinoma endometrium from tertiary cancer center in India
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histologically confirmed non.
- •metastatic endometrial cancer.
- •Patients staged using both the FIGO 2023 and FIGO 2009 systems.
- •Eastern Co-operative Oncology Group (ECOG) performance score 0-
- •Patients who consent to molecular testing.
排除标准
- •1.Patients who have received prior treatment for endometrial cancer.
- •2.Patients with incomplete clinical or pathological data 3.Uterine sarcoma 4.Prior pelvic radiotherapy, hormonal therapy or chemotherapy 5.Those unfit for chemotherapy and radiation therapy.
结局指标
主要结局
To evaluate the stage migration in patients with endometrial cancer staged with FIGO 2009 to FIGO 2023 staging system and the outcomes of patients staged with FIGO 2023 staging system.
时间窗: After ethical clearance, 5 years (2 years for patient recruitment, 3 years follow up)
次要结局
- 1.To evaluate how treatment plans differ based on the FIGO 2023 vs. FIGO 2009 staging(2.To incorporate molecular testing [e.g. MMRd (MSI IHC), POLE, p53] in staging and explore its potential impact on prognosis and treatment.)
研究者
RAJKRISHNA B
AMALA INSTITUTE OF MEDICAL SCIENCES