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Trial Title:
Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence
NCT ID:
NCT06237946
Condition:
FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma
Conditions: Official terms:
Carcinoma
Adenomyoepithelioma
Adenocarcinoma, Clear Cell
Recurrence
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 15, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Collaborator:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
Tokyo University
Agency class:
Other
Collaborator:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06237946
