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A prospective study evaluating the role of immune cells within ovarian cancer tissue in understanding the behaviour of high-grade serous ovarian cancer.

Does Tumor Infiltrating Lymphocytes Contribute in Understanding Biological Behaviour of HGSOC? A Prospective Exploratory Study - UnTIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/112826
Enrollment
130
Registered
2026-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C56- Malignant neoplasm of ovary

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

nil
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactAnik Ghosh

Tata Medical Center

ghosh.anik@gmail.com9831220411

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026