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

Not yet recruiting

• Conditions: FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma

• Registration Number: NCT06237946
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Study Start: 2024-03-15
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 272

Inclusion Criteria

• Women aged ≥20 years old.
• Participant with histologically confirmed OCCC of stage IC2, IC3, IIA and IIB by International Federation of Gynecology and Obstetrics (FIGO) 2014 system.
• Participant has received platinum-based regimens for 3 to 6 cycles combined with paclitaxel, gemcitabine, cyclophosphamide, or bevacizumab adjuvant therapy following debulking surgery.
• Formalin-fixed paraffin-embedded (FFPE) tissue samples available.

Exclusion Criteria

• Absence of histological confirmation of the diagnosis.
• Unusable sample or biologically deteriorated.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of recurrence	up to 24 months	The clinical recurrence will be defined as disease progression. Analysis of the eligible histologically confirmed OCCC archival samples from Taiwan, Japan, and Korea that underwent immune-related gene expression will be provided.

Secondary Outcome Measures

Name	Time	Method
2-year PFS	up to 24 months	PFS will be defined as the interval from the surgery date to clinically defined recurrence, disease progression or the last follow-up. PFS will be analyzed using the Kaplan-Meier method, and survival curves will be provided.
5-year OS	up to 60 months	OS will be calculated from the surgery date to the date of death or the last follow-up. OS will be analyzed using the Kaplan-Meier method, and survival curves will be provided.
Outcomes for adjuvant treatment with paclitaxel-based chemotherapy	up to 60 months	Hazard ratio (HR) will be evaluated. These data will be analyzed using the Cox proportional hazards model and the Multivariable Cox proportional hazards model.