UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019754 |
|---|---|
| Receipt number | 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 20:25:02 |
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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
| Obstetrics 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
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
kenta9sp@oita-u.ac.jp
Sponsor or person
Institute
Kansai Clinical Oncology Group - Gynecologic Cancer Group -
Institute
Department
Personal name
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
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
Value
https://center6.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 |
