UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006747 |
|---|---|
| Receipt number | R000007964 |
| Scientific Title | Evaluation of a chemiluminescent immunoassay for serum HE4 |
| Date of disclosure of the study information | 2011/12/09 |
| Last modified on | 2013/07/08 14:59:16 |
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Basic information
Public title
Evaluation of a chemiluminescent immunoassay for serum HE4
Acronym
Evaluation of serum HE4 assay
Scientific Title
Evaluation of a chemiluminescent immunoassay for serum HE4
Scientific Title:Acronym
Evaluation of serum HE4 assay
Region
| Japan |
Condition
Condition
Ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of HE4 assay - reference interval, cutoff, sensitivity and specificity
Basic objectives2
Others
Basic objectives -Others
Performance evaluation of a diagnostic test
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, Specificity
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. Ovarian tumor
- Female 20years oled or above, less than 80 years old.
- Ovarian mass suspected by ultrasound, MRI, or CT. Undergoing laparotomy/surgery.
- The first treatment is a laparotomy/surgery.
- Pathology results available within the study period.
2. Healthy subjects
- Female 20years oled or above, less than 80 years old.
Key exclusion criteria
1. Ovarian tumor
- The dirst treatment is chemotherapy and/or radiotherapy, not laparotomy/surgery.
- Pathology results on the primary tumor not available.
2. Healthy subjects
- History of bilateral oophorectomy.
- Abnormality found in ovary by MRI or PET.
- Aware of gynecological diseases.
- Aware of internal diseases.
- Aware of pregnancy.
Target sample size
470
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Ochiai |
Organization
The Jikei University School of Medicine
Division name
Obstetrics & Gynecology
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Obstetrics & Gynecology
Zip code
Address
3-25-8 Nishishinbashi, Minato-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Abbott Japan Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Abbott Japan Co.,Ltd.
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
東京慈恵会医科大学 附属病院(東京都)
東京慈恵会医科大学 附属柏病院(千葉県)
自治医科大学 附属病院(栃木県)
がん研有明病院(東京都)
立正佼成会附属佼成病院(東京都)
愛知県がんセンター中央病院(愛知県)
聖授会OCAT予防医療センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 09 | Day |
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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case-Control study
Management information
Registered date
| 2011 | Year | 11 | Month | 18 | Day |
Last modified on
| 2013 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007964
