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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005417
Receipt No. R000006427
Scientific Title Treatment outcome and reproductive function of patients with yolk sac tumor (YST) of the ovary in Japan; A retrospective study
Date of disclosure of the study information 2011/04/11
Last modified on 2016/10/18

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Basic information
Public title Treatment outcome and reproductive function of patients with yolk sac tumor (YST) of the ovary in Japan; A retrospective study
Acronym A study for YST
Scientific Title Treatment outcome and reproductive function of patients with yolk sac tumor (YST) of the ovary in Japan; A retrospective study
Scientific Title:Acronym A study for YST
Region
Japan

Condition
Condition Yolk sac tumor (YST) of the ovary
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify improvement of outcome in patients with YST by transitions of the standard treatment.
Basic objectives2 Others
Basic objectives -Others Retrospective study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Recurrence-free survival
Key secondary outcomes Overall survival
Rate of patients with recuperation of menstruation cycle after treatment
Rate of patients who became pregnancy after treatment
Rate of patients who got child after treatment

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

Not applicable
Gender Female
Key inclusion criteria Patients with YST (including the mixed type) who received any treatment from January 1st, 1980 to December 31st, 2007.
Key exclusion criteria Not applicable
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Yoshikawa
Organization Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name Department of Obstetrics and Gynecology
Zip code
Address Tennoudai 1-1-1, Tsukuba, Ibaraki, Japan
TEL 029-853-3049
Email hyoshi@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyomi Satoh
Organization Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name Department of Obstetrics and Gynecology
Zip code
Address Tennoudai 1-1-1, Tsukuba, Ibaraki, Japan
TEL 029-853-3073
Homepage URL
Email toyomi-s@md.tsukuba.ac.jp

Sponsor
Institute Gynecologic Cancer Study Group of Japan Clinical Oncology Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道大学病院 産婦人科(北海道)
札幌医科大学 産婦人科(北海道)
岩手医科大学 産婦人科(岩手県)
東北大学病院 産婦人科(宮城県)
筑波大学臨床医学系 産婦人科(茨城県)
防衛医科大学校 産婦人科(埼玉県)
埼玉県立がんセンター 婦人科(埼玉県)
埼玉医科大学総合医療センター 産婦人科(埼玉県)
東京慈恵会医科大学附属柏病院 産婦人科(千葉県)
国立がん研究センター中央病院 婦人科(東京都)
がん・感染症センター都立駒込病院 産婦人科(東京都)
東京慈恵会医科大学附属病院 産婦人科(東京都)
癌研究会有明病院 婦人科(東京都)
東京大学医学部 産婦人科(東京都)
順天堂大学医学部 産婦人科(東京都)
北里大学医学部 産婦人科(神奈川県)
新潟県立がんセンター新潟病院 産婦人科(新潟県)
信州大学医学部 産婦人科(長野県)
愛知県がんセンター中央病院 婦人科(愛知県)
京都大学医学部附属病院 産婦人科/婦人科学産科学教室(京都府)
大阪市立大学医学部附属病院 産婦人科学(大阪府)
22) 近畿大学医学部 産婦人科(大阪府)
大阪府立病院機構大阪府立成人病センター 婦人科(大阪府)
大阪市立総合医療センター 婦人科(大阪府)
近畿大学医学部堺病院 産婦人科(大阪府)
兵庫県立成人病センター 婦人科(兵庫県)
鳥取大学医学部 産婦人科(鳥取県)
国立病院機構呉医療センター・中国がんセンター 産婦人科(広島県)
国立病院機構四国がんセンター 婦人科(愛媛県)
国立病院機構九州がんセンター 婦人科(福岡県)
久留米大学医学部 産婦人科(福岡県)
九州大学病院 産婦人科(福岡県)
佐賀大学医学部 産婦人科(佐賀県)
熊本大学医学部 産科婦人科(熊本県)
鹿児島市立病院 産婦人科(鹿児島県)
琉球大学医学部 産婦人科(沖縄県)
埼玉国際医療センター 婦人科(埼玉県)
東邦大学医療センター大橋病院 産婦人科(東京都)
NTT東日本関東病院 産婦人科(東京都)
順天堂大(練馬病院) 産婦人科(東京都)
静岡県立静岡がんセンター 婦人科(静岡県)
名古屋大学附属病院 産婦人科(愛知県)
京都府立医科大学 産婦人科(京都府)
島根大学医学部 産婦人科(島根県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0959804914011642
Number of participants that the trial has enrolled
Results
RESULTS:
There were 211 patients enrolled from 43 institutions. The BEP regimen and a non-BEP regimen were administered to 112 and 99 patients as postoperative chemotherapy, respectively. BEP was significantly superior to non-BEP in 5-year OS (93.6% versus 74.6%, P=0.0004). Reduced-dose BEP was significantly associated with poorer 5-year OS compared with standard-dose BEP (89.4% versus 100%, P=0.02 and 62.5% versus 96.9%, P=0.0002). All patients who underwent fertility-sparing surgery recovered their menstrual cycles. Sixteen of 23 patients receiving BEP (70.0%) and 13 of 17 patients receiving non-BEP (76.5%) who were nulliparous at fertility-sparing surgery and married at the time of investigation gave birth to 21 and 19 healthy children, respectively.
CONCLUSIONS:
The results of the present study suggest that standard-dose BEP should be administered for ovarian YST. BEP is as safe as non-BEP for preserving reproductive function.
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 Completed
Date of protocol fixation
2011 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 11 Month 30 Day

Other
Other related information Satoh T, et al. Administration of standard-dose BEP regimen (bleomycin+etoposide+cisplatin) is essential for treatment of ovarian yolk sac tumor. Eur J Cancer 2015;51:340-51.

Management information
Registered date
2011 Year 04 Month 09 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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