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

NCT ID: NCT06237946

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 272 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2024-12-31

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.

Conditions

FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Tokyo University

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ling-Hung Wei

Role: CONTACT

weilh1966@gmail.com

+886-23123456

Other Identifiers

202310152RIND

Identifier Type: -

Identifier Source: org_study_id