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

NCT06237946 | Unknown

• 1 other identifier: 202310152RIND
• Study Type: observational
• Target: 272
• Locations: 0 countries
• Sites: N/A

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.

Conditions

FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Presence of recurrence

  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 Outcomes (3)

• 2-year PFS

  up to 24 months

• 5-year OS

  up to 60 months

• Outcomes for adjuvant treatment with paclitaxel-based chemotherapy

  up to 60 months

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Chang Gung Memorial Hospital: collaborator
• Tokyo University: collaborator
• Samsung Medical Center: collaborator

Central Study Contacts

Ling-Hung Wei

CONTACT

+886-23123456; weilh1966@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 2, 2024
• Study Start: March 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share