UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046404 |
|---|---|
| Receipt number | R000052930 |
| Scientific Title | A clinical study to identify biomarkers for determining the malignant potential of ovarian immature teratoma |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2022/03/18 19:29:20 |
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Basic information
Public title
A clinical study to identify biomarkers for determining the malignant potential of ovarian immature teratoma
Acronym
A clinical study to identify biomarkers for determining the malignant potential of ovarian immature teratoma
Scientific Title
A clinical study to identify biomarkers for determining the malignant potential of ovarian immature teratoma
Scientific Title:Acronym
A clinical study to identify biomarkers for determining the malignant potential of ovarian immature teratoma
Region
| Japan |
Condition
Condition
ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the expression of Octamer-binding transcription factor4 (Oct4) in tumor immature neuroepithelium and tumor grade and recurrence in patients with ovarian immature teratoma.
Basic objectives2
Others
Basic objectives -Others
To determine the relationship between the grade of ovarian immature teratoma cases using existing grading systems and grade of ovarian immature teratoma by the existing grading system and the expression of Oct4 in the excised specimen.
To clarify the relationship between the expression of Oct4 in explanted specimens and the prognosis in patients with ovarian immature teratoma who did not receive postoperative adjuvant chemotherapy.
To clarify the relationship between Oct4 expression in explanted specimens and prognosis in patients with ovarian immature teratoma who received postoperative adjuvant chemotherapy.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oct4 expression by immunohistochemical staining.
Recurrence within 1 year after surgery
Key secondary outcomes
Grade of immature teratoma by central pathological diagnosis.
Factors influencing prognosis: age, FIGO stage, surgical procedure, and adjuvant chemotherapy.
Adjuvant chemotherapy and number of cycles
1)Recurrence free survival,2) Overall survival
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
| Not applicable |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who underwent surgical removal of immature teratoma of the ovary during the 20-year period between January 2001 and December 2020.
Patients whose HE-stained and formalin-fixed paraffin-embedded specimens of the excised tumor are preserved at the treating institution.
Key exclusion criteria
Patients with mixed tumors with other malignant germ cell tumors.
Patients who have expressed their refusal to partici
pate in the study.
Patients who are judged by the principal investigator or sub-investigator to be inappropriate for participation in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Abiko |
Organization
NHO Kyoto Medical Center
Division name
Clinical Research Center / Obstetrics and Gynecology
Zip code
612-8555
Address
1-1 Mukaibatake cho, Fukakusa, Fushimiku, Kyoto City, Kyoto
TEL
075-641-9161
kaoruvc@gmail.com
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Abiko |
Organization
NHO Kyoto Medical Center
Division name
Clinical Research Center / Obstetrics and Gynecology
Zip code
612-8555
Address
1-1 Mukaibatake cho, Fukakusa, Fushimiku, Kyoto City, Kyoto
TEL
075-641-9161
Homepage URL
kaoruvc@gmail.com
Sponsor or person
Institute
NHO Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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
| 2022 | Year | 03 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study to investigate the relationship between the expression of Octamer-binding transcription factor4 (Oct4) in tumor immature neuroepithelium and tumor grade and recurrence in patients with ovarian immature teratoma.
Management information
Registered date
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052930
