UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015177 |
|---|---|
| Receipt number | R000015234 |
| Scientific Title | The effect of omission of second evacuation for hydatidiform mole on the incidence of post-molar trophoblastic disease |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2016/09/20 12:54:49 |
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Basic information
Public title
The effect of omission of second evacuation for hydatidiform mole on the incidence of post-molar trophoblastic disease
Acronym
The effect of second evacuation for hydatidiform mole
Scientific Title
The effect of omission of second evacuation for hydatidiform mole on the incidence of post-molar trophoblastic disease
Scientific Title:Acronym
The effect of second evacuation for hydatidiform mole
Region
| Japan |
Condition
Condition
hydatidiform mole
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Japanese standard treatment for hydatidiform mole is peforming a second curettage one week after first evacuation. The aim is investigating that the ratio of post-molar trophoblastic diseases is not worse without a second curettage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The ratio of post-molar trophoblastic diseases is not worse without a second curettage.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
clinical diagnosis by ultrasound and serum level of hCG is hydatidiform mole
Key exclusion criteria
younger than 20 years old
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Niimi |
Organization
Nagoya Graduate University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2261
kaorun@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Niimi |
Organization
Nagoya Graduate University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2261
Homepage URL
kaorun@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Graduate University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya Graduate University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
follow-up for developing to trophoblastic tumors after an evacuation by measuring serum hCG
Management information
Registered date
| 2014 | Year | 09 | Month | 16 | Day |
Last modified on
| 2016 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015234
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| Registered date | File name |
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