UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000019710 |
| Receipt No. | R000022763 |
| Scientific Title | A retrospective study of treatments and prognosis of neuroendocrine tumor of endometrium |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2019/11/12 (Ver. 9) |
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| Basic information | ||
| Public title | A retrospective study of treatments and prognosis of neuroendocrine tumor of endometrium | |
| Acronym | A retrospective study of neuroendocrine tumor of endometrium | |
| Scientific Title | A retrospective study of treatments and prognosis of neuroendocrine tumor of endometrium | |
| Scientific Title:Acronym | A retrospective study of neuroendocrine tumor of endometrium | |
| Region |
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| Condition | ||
| Condition | Neuroendocrine tumor of endometrium | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To clarify treatment and prognosis of neuroendocrine tumor of endometrium, and to obtain findings to establish future individualized treatment. |
| Basic objectives2 | Others |
| Basic objectives -Others | Retrospective observational study |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | background factors, stage, tratments, pathological findings, prognosis |
| Key secondary outcomes | |
| 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 |
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| Age-upper limit |
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| Gender | Female | |||
| Key inclusion criteria | Patients diagnosed with neuroendocrine tumor of endometrium between 1995 and 2014. | |||
| Key exclusion criteria | 1) Patients with a history of chemotherapy and/or radiotherapy for other malignancy.
2) Patients with a severe complication. 3) Patients who have other malignancies. |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Faculty of Medicine, Oita University | ||||||
| Division name | Department of Obstetrics and Gynecology | ||||||
| Zip code | 8795593 | ||||||
| Address | 1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita 8795593, Japan | ||||||
| TEL | 097-586-5922 | ||||||
| matumoti@oita-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Faculty of Medicine, Oita University | ||||||
| Division name | Department of Obstetrics and Gynecology | ||||||
| Zip code | 8795593 | ||||||
| Address | 1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita 8795593, Japan | ||||||
| TEL | 097-586-5922 | ||||||
| Homepage URL | |||||||
| matumoti@oita-u.ac.jp | |||||||
| Sponsor | |
| Institute | Kansai Clinical Oncology Group |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Kansai Clinical Oncology Group |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Department of Obstetrics and Gynecology, Faculty of Medicine, Oita University |
| Address | 1-1, Idaigaoka, Hasama-machi, Yufu-shi, Oita 8795593, Japan |
| Tel | 097-586-5120 |
| syomu@oita-u..ac.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 |
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| Related information | |
| URL releasing protocol | http://www.med.oita-u.ac.jp/sanka/patient/index5.html |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103 | ||||||
| Number of participants that the trial has enrolled | 42 | ||||||
| Results | Please refer to the link below. https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103 |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results |
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| Baseline Characteristics | Please refer to the link below. https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103 |
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| Participant flow | Please refer to the link below. https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103 |
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| Adverse events | Not applicable |
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| Outcome measures | Please refer to the link below. https://www.ejgo.org/DOIx.php?id=10.3802/jgo.2019.30.e103 |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date analysis concluded | |||||||
| Other | |
| Other related information | This is a multi-center retrospective study. |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022763 |
