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

NCT06237946 — Unknown, 272 participants, National Taiwan University Hospital

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

Registry	NCT06237946
Status	Unknown
Study type	Observational
Enrollment	272 (Estimated)
Sponsor	National Taiwan University Hospital (Other); collaborators: Chang Gung Memorial Hospital, Tokyo University, Samsung Medical Center
Conditions	FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma
Dates	start 2024-03-15 (estimated), primary completion 2024-10-31 (estimated), completion 2024-12-31 (estimated), first posted 2024-02-02, last updated 2024-02-23

-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.

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+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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: Female, ages: 20 Years to any

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.