UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063461 |
|---|---|
| Receipt number | R000072635 |
| Scientific Title | Investigation of Clinical Outcomes and Mechanisms Regulating Carcinogenesis in Serous Tubal Intraepithelial Carcinoma (JGOG3038 / EAGOT-OV-001) |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/29 14:42:24 |
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Basic information
Public title
Investigation of Clinical Outcomes and Mechanisms Regulating Carcinogenesis in Serous Tubal Intraepithelial Carcinoma (JGOG3038 / EAGOT-OV-001)
Acronym
Investigation of Serous Tubal Intraepithelial Carcinoma (JGOG3038 / EAGOT-OV-001)
Scientific Title
Investigation of Clinical Outcomes and Mechanisms Regulating Carcinogenesis in Serous Tubal Intraepithelial Carcinoma (JGOG3038 / EAGOT-OV-001)
Scientific Title:Acronym
Investigation of Serous Tubal Intraepithelial Carcinoma (JGOG3038 / EAGOT-OV-001)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Serous tubal intraepithelial carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the clinical outcomes, pathological features, and molecular characteristics of serous tubal intraepithelial carcinoma (STIC), serous tubal intraepithelial lesion (STIL), and p53 signature in Japan. Stage 1 collects clinical and outcome data to evaluate progression-free survival of STIC and its association with post-diagnosis management. Stage 2 establishes an integrated pathological classification (FLAT/BLAD type, nuclear/cytoplasmic p53 pattern, Ki-67) by central pathology review. Stage 3 explores molecular mechanisms of carcinogenesis and progression to high-grade serous carcinoma by whole exome sequencing, FISH, and related analyses. The study aims to validate STIC as a target for ovarian cancer prevention and to provide a basis for management guidance after STIC diagnosis.
Basic objectives2
Others
Basic objectives -Others
Clinical outcomes and mechanisms regulating carcinogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival of patients with serous tubal intraepithelial carcinoma
Key secondary outcomes
1. Overall survival
2. Cumulative incidence of peritoneal, ovarian, and fallopian tube cancer
3. Exploratory comparison of PFS and OS by management after diagnosis, by surgical background, by presence of BRCA1/2 pathogenic variants, and by pathological subtype
4. Association between the novel pathological classification by central review and prognosis
5. Association of molecular profiles with clinicopathological factors and prognosis
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. Patients who, by December 2026, have undergone one of the following surgeries and were diagnosed with STIC, STIL, or the p53 signature based on a pathological examination of the excised fallopian tube:
･ Risk-reducing salpingo-oophorectomy performed on patients with pathogenic BRCA1/2 variants, etc.
･ Salpingectomy performed for benign gynecological conditions
･ Salpingectomy performed for ovarian cancer, fallopian tube cancer, or peritoneal cancer
2. Patients who were 18 years of age or older at the time of surgery
3. Patients whose existing information and existing samples may be used for research in accordance with methods approved by the ethics review committees of each research institution
Key exclusion criteria
1. Patients for whom a refusal to participate in the study has been confirmed
2. Patients for whom the minimum clinical information required for analysis of the primary endpoint cannot be obtained (however, cases for which only central pathology review or exploratory analysis is possible will be handled separately in accordance with the purpose of the respective analysis)
3. Other patients whom the principal investigator or the study director has determined to be unsuitable for inclusion in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Obstetrics and Gynecology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3073
kobayashi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Obstetrics and Gynecology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3073
Homepage URL
https://jgog.gr.jp/
kobayashi@md.tsukuba.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group (JGOG)
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
East Asian Gynecologic Oncology Trial Group (EAGOT)
Korean Gynecologic Oncology Group (KGOG)
Taiwan Gynecologic Oncology Group (TGOG)
Chinese SOciety of Gynecologic Oncology (CHISGO)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
0298533073
t-credo.adm@un.tsukuba.ac.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
JGOG/EAGOT/KGOG/TGOG/CHISGO参加施設
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://jgog.gr.jp/
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
International collaborative research with the Korean Society of Gynecologic Oncology (KGOG), the Taiwan Society of Gynecologic Oncology (TGOG), and the Chinese Society of Gynecologic Oncology (CHISGO), conducted under the framework of the East Asian Gynecologic Oncology Trial Group (EAGOT)
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072635
