UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055837 |
|---|---|
| Receipt number | R000063275 |
| Scientific Title | Multi-center collaborative study to elucidate the frequency of Folate Receptor-Alpha (FRalpha) biomarker expression in advanced/recurrent ovarian cancer patient |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2025/10/15 09:21:57 |
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Basic information
Public title
Multi-center collaborative study to elucidate the frequency of Folate Receptor-Alpha (FRalpha) biomarker expression in advanced/recurrent ovarian cancer patient
Acronym
Multi-center collaborative study to elucidate the frequency of Folate Receptor-Alpha (FRalpha) biomarker expression in advanced/recurrent ovarian cancer patient
Scientific Title
Multi-center collaborative study to elucidate the frequency of Folate Receptor-Alpha (FRalpha) biomarker expression in advanced/recurrent ovarian cancer patient
Scientific Title:Acronym
Multi-center collaborative study to elucidate the frequency of Folate Receptor-Alpha (FRalpha) biomarker expression in advanced/recurrent ovarian cancer patient
Region
| Japan |
Condition
Condition
ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the frequency of FRalpha expression in ovarian tumor tissue in ovarian cancer patients in Japan.
Basic objectives2
Others
Basic objectives -Others
To clarify the frequency of FRalpha expression and clinical characteristics in ovarian tumor tissue in ovarian cancer patients in Japan.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FRalpha positivity rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Japanese female patients aged 18 years or older at the time of obtaining consent
2. Patients with a confirmed diagnosis of High-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
3. Patients willing to submit a neutral buffered formalin-fixed paraffin-embedded (FFPE) block of tumor tissue for storage or a newly prepared FFPE thin section with a designated glass slide
4. Enrollment Criterion A only: Patients with platinum-resistant disease:
a. Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and <= 6 months after the date last dose of platinum
b. Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum.
Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression
Note: Patients who are platinum-refractory during front-line treatment are excluded (see exclusion criteria).
5. Enrollment Criterion B only: Patients with platinum-sensitive disease:
a. Patients undergoing platinum-containing chemotherapy in combination with bevacizumab after platinum-sensitive recurrence
6. Patients who are judged by the principal investigator or sub-investigator to have the ability to understand and comply with the contents of the clinical study
7. Patients who are able to sign and date the Informed consent form prior to enrollment in the study
Key exclusion criteria
1. Patients for whom there are not enough specimens for the study
2. Endometrioid, clear cell, mucinous or sarcoma histology or any of these histological types Patients with mixed oncology or low-atypical or borderline ovarian oncology.
3. Enrollment Criterion A only: Patients who demonstrated platinum refractory during first-line therapy
4. Other patients who are judged to be inappropriate for the study by the principal investigator or sub-investigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Hasegawa |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gynecologic Oncology
Zip code
350-1298
Address
1397-1, Yamane, Hidaka City ,Saitama, japan
TEL
042-984-4111
koseih@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yabuno |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gynecologic Oncology
Zip code
350-1298
Address
1397-1, Yamane, Hidaka City ,Saitama, japan
TEL
042-984-4111
Homepage URL
yakira@saitama-med.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Gynecologic Oncology Group
Address
4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, JAPAN
Tel
03-5206-1982
info@jgog.gr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter, retrospective, non-interventional research study that collects data on the positivity rate, incidence rate, and clinical characteristics of FRalpha (pharmacotherapy content and treatment effect) in patients with advanced or recurrent ovarian cancer.
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063275
