Real-world clinical and molecular profile of ovarian cancer patients treated with Olaparib: study protocol and design of the OC-REAL India multicentre ambispective observational study

Narayanankutty Warrier; Ghanashyam Biswas; Dipanjan Panda; Anita Ramesh; Devang Sarvaiya; Sucheta Mehta; Senthilnathan Mohanasundaram; Jaideep Gogtay

doi:10.18203/2349-3933.ijam20263724

Authors

Narayanankutty Warrier
Ghanashyam Biswas
Dipanjan Panda
Anita Ramesh
Devang Sarvaiya Cipla Ltd., Peninsula Business Park, Ganapatrao Kadam Marg, Lower Parel West, Mumbai, Maharashtra 400013
Sucheta Mehta
Senthilnathan Mohanasundaram
Jaideep Gogtay

DOI:

https://doi.org/10.18203/2349-3933.ijam20263724

Keywords:

Ovarian cancer, PARP, Olaparib, maintenance therapy, BRCA, HRD, Real-world evidence, Targeted therapy

Abstract

Background: Globally, ovarian cancer (OC) is the eighth most common cancer among women, accounting for an estimated 3.7% of all cases and 4.7% of cancer-related deaths. Approximately 20-25% of OC cases harbour germline BRCA1/2 mutations, while homologous recombination deficiency (HRD) has emerged as an important therapeutic biomarker. Poly (ADP-ribose) polymerase (PARP) inhibitors, such as Olaparib, have demonstrated significant clinical benefit as maintenance therapy in patients with BRCA-mutated or HRD-positive OC. However, real-world Indian data on the clinical and molecular characteristics of patients receiving Olaparib remain limited. The objective of the study was to evaluate the clinical, molecular, and treatment profile of OC patients receiving Olaparib maintenance therapy.

Methods: This ambispective, cross-sectional, multicentre, non-interventional, real-world evidence study aims to enrol 250 Indian OC patients initiated on Olaparib maintenance therapy. Data will be captured electronically at a baseline visit using an electronic data capture (EDC) system. Variables include demographics, comorbidities, family cancer history, histopathology, surgical and treatment history, BRCA mutation and HRD status, CA-125 levels at diagnosis and prior to Olaparib initiation, and details of maintenance therapy.

Conclusions: OC-REAL India study will provide real-world insights into Indian OC patients on Olaparib, including demographics, pathology, and BRCA/HRD mutation prevalence. Findings aim to support personalized treatment and improve clinical outcomes. As this is an ongoing study, the results are expected to be published after completion of the study.

Trial registration: The study was registered with the Clinical Trials Registry-India (CTRI; Registration No. CTRI/2025/08/092561)

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