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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000027404 |
Receipt No. | R000031382 |
Scientific Title | A cohort study of the target protein as a novel tumor marker for patients with ovarian clear cell carcinoma befor or after surgery. |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/08/29 |
Basic information | ||
Public title | A cohort study of the target protein as a novel tumor marker for patients with ovarian clear cell carcinoma befor or after surgery. | |
Acronym | A cohort study of a novel ovarian CCC tumor marker | |
Scientific Title | A cohort study of the target protein as a novel tumor marker for patients with ovarian clear cell carcinoma befor or after surgery. | |
Scientific Title:Acronym | A cohort study of a novel ovarian CCC tumor marker | |
Region |
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Condition | ||
Condition | Ovarian clear cell carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | We examine complementarity and subsidiarity of the target protein and CA125 measurement at the time of the follow-up from pre to post-operation. |
Basic objectives2 | Others |
Basic objectives -Others | Practical clinical use of the target protein as a novel serum tumor marker |
Trial characteristics_1 | Others |
Trial characteristics_2 | Others |
Developmental phase |
Assessment | |
Primary outcomes | Changes in serum levels of target protein and CA125 before and after surgery(every 1-3 month) |
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 | |
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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 | 1. Patinets whose pre-treatment serum samples are obetained.
2.Patients who submitted the documment for written informed consent |
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Key exclusion criteria | 1. Patients who are judged as being inappropriate for this study.
2. Patients during pregnancy |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kochi Health Science Center | ||||||
Division name | Gynecology | ||||||
Zip code | |||||||
Address | 2125-1, Ike, Kochi-city, Kochi-pref | ||||||
TEL | 088-837-3000 | ||||||
yuusuke_kunimi@khsc.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kochi Health Science Center | ||||||
Division name | Gynecology | ||||||
Zip code | |||||||
Address | 2125-1, Ike, Kochi-city, Kochi-pref | ||||||
TEL | 088-837-3000 | ||||||
Homepage URL | |||||||
yuusuke_kunimi@khsc.or.jp |
Sponsor | |
Institute | Kochi Health Science Center |
Institute | |
Department |
Funding Source | |
Organization | Tosoh Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 高知医療センター(高知県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Samples will be analyzed accrodingly. |
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=R000031382 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |