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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019754
Receipt No. R000022813
Scientific Title Clinical and prognostic significance of pathological reclassification in ovarian neuroendocrine tumors: a retrospective study (O-NET study)
Date of disclosure of the study information 2015/11/11
Last modified on 2020/05/15

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Basic information
Public title Clinical and prognostic significance of pathological reclassification
in ovarian neuroendocrine tumors: a retrospective study (O-NET study)
Acronym Clinical and prognostic significance of pathological reclassification
in ovarian neuroendocrine tumors: a retrospective study (O-NET study)
Scientific Title Clinical and prognostic significance of pathological reclassification
in ovarian neuroendocrine tumors: a retrospective study (O-NET study)
Scientific Title:Acronym Clinical and prognostic significance of pathological reclassification
in ovarian neuroendocrine tumors: a retrospective study (O-NET study)
Region
Japan

Condition
Condition Primary ovarian neuroendocrine tumors
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the versatility of the novel WHO 2010 classification for gastrointestinal neuroendocrine tumors to the primary ovarian neuroendocrine tumors.
Basic objectives2 Others
Basic objectives -Others We retrospectively classified ovarian neuroendocrine tumors according to the novel WHO 2010 classification for gastrointestinal neuroendocrine tumors.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival time
Key secondary outcomes Progression free survival time

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 pathologically diagnosis of primary ovarian neuroendocrine tumor for the periods from 1995 to 2014.
Key exclusion criteria Multiple malignancies within five years.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Kai
Organization Oita University Faculty of Medinice
Division name Department of Obstetrics and Gynecology
Zip code 879-5593
Address 1-1 Idaigaoka, Hasama-machi, Yufu City, Oita 879-5593, Japan
TEL 097-586-5922
Email kenta9sp@oita-u.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Kai
Organization Oita University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 879-5593
Address 1-1 Idaigaoka, Hasama-machi, Yufu City, Oita 879-5593, Japan
TEL 097-586-5922
Homepage URL
Email kenta9sp@oita-u.ac.jp

Sponsor
Institute Kansai Clinical Oncology Group - Gynecologic Cancer Group -
Institute
Department

Funding Source
Organization Kansai Clinical Oncology Group - Gynecologic Cancer Group -
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor SGSG (Sankai Gynecology Study Gruop), TGCU (Tohoku Gynecologic Cancer Unit), GOTIC (Gynecologic Oncology Trial and Investigation Consortium of North Kanto), GOGO (Gynecologic Oncology Gruop of Osaka), WJGOG (Weas Japan Gynecologic Oncology Gruop)
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Oita University Faculty of Medicine (1st General Affairs Division)
Address 1-1 Idaigaoka, Hasama-machi, Yufu City, Oita 879-5593, Japan
Tel 097-586-5120
Email syomu@oita-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 KCOG-G1502s
Org. issuing International ID_1 Kansai Clinical Oncology Group - Gynecologic Cancer Group -
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大分大学病院(大分県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 11 Day

Related information
URL releasing protocol http://www.med.oita-u.ac.jp/sanka/patient/index6.html
Publication of results Published

Result
URL related to results and publications https://www.karger.com/Article/Abstract/506743
Number of participants that the trial has enrolled 48
Results
Of the 68 enrolled patients, 48 were eligible for analysis. All carcinoids (n = 32) were reclassified as NET G1/G2, whereas 14 of 16 carcinomas were reclassified as NEC/mixed adeno-NEC (MANEC) (Fisher exact test; p < 0.01). The OS/PFS was 49.0/42.5 months and 6.5/3.9 months for NET G1/G2 and NEC/MANEC, respectively. Histology revealed that NEC/MANEC was associated with increased risk of death (HR = 48.0; 95% CI, 3.93-586; p < 0.01) and disease progression (HR = 51.6; 95% CI, 5.54-480; p < 0.01). 
Results date posted
2020 Year 05 Month 15 Day
Results Delayed
Delay expected
Results Delay Reason Longer period needed than our expectation for central pathological review.
Date of the first journal publication of results
2020 Year 02 Month 25 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 07 Month 24 Day
Date of IRB
2015 Year 06 Month 16 Day
Anticipated trial start date
2015 Year 11 Month 11 Day
Last follow-up date
2017 Year 08 Month 30 Day
Date of closure to data entry
2017 Year 08 Month 30 Day
Date trial data considered complete
2018 Year 05 Month 17 Day
Date analysis concluded
2018 Year 10 Month 11 Day

Other
Other related information We retrospectively classified ovarian neuroendocrine tumors according to the novel WHO 2010 classification for gastrointestinal neuroendocrine tumors to evaluate the prognostic value of the WHO 2010 classification in ovarian neuroendocrine tumors.

Management information
Registered date
2015 Year 11 Month 11 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022813

Research Plan
Registered date File name
2017/05/13 KCOG-G1502s_卵巣がん研究_実施計画書v1.5.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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