UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	kaoruvc@gmail.com

Sponsor
Institute	NHO Kyoto Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052930