NCT06237946

Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence

A Retrospective, Open-label, Biomarker Study for Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 272 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to determine the risk of recurrence in early-stage OCCC (Ovarian Clear Cell Carcinoma) patients who received postoperative adjuvant treatment. Participants were received platinum-based adjuvant therapy following debulking surgery will be included for the study.

Detailed description

This is a retrospective, global multicenter, single-arm, study for early-stage OCCC (Ovarian Clear Cell Carcinoma) patients at risk of recurrence following the first-line treatment. This study is planned to enroll 272 patients eligible for participation from two study sites in Taiwan, one in Korea, and one in Japan. The study will use archival Formalin-Fixed Paraffin-Embedded (FFPE) samples from patients who have received adjuvant therapy following debulking surgery. The study is designed to identify OCCC patients at risk for relapse and apply clinical stratification by IHC staining of 3 selected markers (CD45, CD8, tryptase) to prepare as clinical assays.

Conditions

• FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma

Timeline

• Start date: 2024-03-15
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2024-02-02
• Last updated: 2024-02-23