Health Condition 1: C56- Malignant neoplasm of ovary
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Agemore than or equal to 18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 3 3. Informed written consent obtained 4. Histologically confirmed diagnosis of HGSOC 5. FIGO stage IIIC and IV where visible omental disease is present 6. Undergoing complete treatment at TMCK
Exclusion criteria
Exclusion criteria: 1. Histological diagnosis other than HGSOC. 2. Prior or synchronous diagnosis of another malignancy. 3. Inadequate or poor-quality tissue samples unsuitable for TIL assessment. 4. Patients receiving primary treatment outside TMCK but attending for recurrent disease. 5. Patients unable to provide informed consent due to physical or mental incapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To measure changes in TILs in the omental tissue of patients with advanced HGSOC before and after neoadjuvant chemotherapy (NACT) and correlate these findings with clinical outcomes with respect to KELIM score and chemotherapy response score (CRS)Timepoint: At diagnosis, 9 weeks, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To correlate cancer recurrence & survival with TILs measurements in advanced HGSOC patients undergoing upfront & interval surgery 2. To identify if TILs influence a. Completeness of cytoreduction (CC score) b. Surgical complexity score (SCS) 3. To describe the spatial distribution of TILs (intra-tumoral or stromal) across tumour tissues 4. If germline BRCA status influences TILs & its change after chemotherapy Timepoint: At diagnosis, 9 & 12 weeks | — |
Countries
India
Contacts
Tata Medical Center