FIGO Stage IC2 to II Ovarian Clear Cell CarcinomaNCT06237946
Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence
An observational study of FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Absence of histological confirmation of the diagnosis.
- Unusable sample or biologically deteriorated.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Secondary outcomes (3)
2-year PFS
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.
Measured: up to 24 months
5-year OS
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.
Measured: up to 60 months
Outcomes for adjuvant treatment with paclitaxel-based chemotherapy
Hazard ratio (HR) will be evaluated. These data will be analyzed using the Cox proportional hazards model and the Multivariable Cox proportional hazards model.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FIGO Stage IC2 to II Ovarian Clear Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Tokyo University, Samsung Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237946
- Sponsor's protocol ID
- 202310152RIND
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Open-label, Biomarker Study for Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence
- ClinicalTrials.gov ID
- NCT06237946
- Acronym / sponsor ID
- 202310152RIND
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Tokyo University, Samsung Medical Center
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Absence of histological confirmation of the diagnosis.
- Unusable sample or biologically deteriorated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
2-year PFS
Time frame: up to 24 months
5-year OS
Time frame: up to 60 months
Outcomes for adjuvant treatment with paclitaxel-based chemotherapy
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling-Hung Wei (+886-23123456, weilh1966@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of recurrence (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.