Health Condition 1: R971- Elevated cancer antigen 125 [CA 125] Health Condition 2: Z789- Other specified health status
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Aster CMI Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1_Age greater than or equal to 18 years 2_Histologically confirmed endometrial carcinoma (all stages) 3_Undergoing surgery at the participating centre 4_Consent for molecular testing and follow-up
Exclusion criteria
Exclusion criteria: 1_Histologic diagnosis other than endometrioid or serous/endometrial carcinoma (e.g., sarcomas) 2_Previous pelvic radiation or chemotherapy 3_Inadequate tumor tissue for molecular analysis 4_Non-consent for molecular testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in risk classification due to molecular panel use Comparison of pre-molecular (clinicopathologic) and post molecular risk group as per 2020 ESGO or ESTRO or ESP guidelines.Timepoint: 1_To evaluate the utility of a molecular endometrial panel (POLE, MMR/MSI, p53 status) for risk stratification in patients with endometrial carcinoma which categorizes patients based on likelihood of disease recurrence or progression, which guides decisions on surgery and adjuvant therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Variables: 1. Recurrence Free Survival (RFS): Defined as time from surgery to documented recurrence or last follow up. Evaluated by molecular subtype (Kaplan-Meier analysis). 2. Overall Survival (OS): Defined as time from surgery to death from any cause or last contact. Stratified by molecular subtype. 3. Adjuvant Treatment Modification Rate: Proportion of patients with altered treatment (addition or omission of chemotherapy or radiation) due to molecular re stratification. 4. Cost effectiveness: Cost per quality-adjusted life year (QALY) gained if feasible Direct cost comparison with conventional approach (without molecular classification)Timepoint: To assess the correlation between molecular subtype & disease-free survival (DFS) & overall survival (OS).To evaluate changes in treatment recommendations based on molecular classification. To assess the feasibility & cost-effectiveness of routine panel use in a real-world clinical setting. | — |
Countries
India
Contacts
Public ContactDr Vijay Ahuja
Aster Whitefield Hospital
Outcome results
None listed