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

February 21, 2024 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A cohort of 272 women with a diagnosis of FIGO stage IC2, IC3, IIA and IIB of OCCC, diagnosed between 2011 and 2021. Patients were received platinum-based adjuvant therapy following debulking surgery will be included for the study. Adjuvant therapy was given according to the NCCN guideline and Institutional Tumor Board.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of recurrence
Time Frame: 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.
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year PFS
Time Frame: 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.
up to 24 months
5-year OS
Time Frame: 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.
up to 60 months
Outcomes for adjuvant treatment with paclitaxel-based chemotherapy
Time Frame: 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.
up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Samsung Medical Center
Chang Gung Memorial Hospital
Tokyo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202310152RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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