UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005729 |
|---|---|
| Receipt number | R000006775 |
| Scientific Title | A pilot study of evaluating the impact on intraoperative ultrasonography to individualize systematic paraaortic lymph node dissection in gynecologic malignancy. |
| Date of disclosure of the study information | 2011/06/06 |
| Last modified on | 2016/07/19 12:42:33 |
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Basic information
Public title
A pilot study of evaluating the impact on intraoperative ultrasonography to individualize systematic paraaortic lymph node dissection in gynecologic malignancy.
Acronym
PAN US study
Scientific Title
A pilot study of evaluating the impact on intraoperative ultrasonography to individualize systematic paraaortic lymph node dissection in gynecologic malignancy.
Scientific Title:Acronym
PAN US study
Region
| Japan |
Condition
Condition
gynecologic malignant disease who is plannig to tumor debulking with paraaortic lymoh nodes dissection
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1)To examine intraoperative ultrasonography detect metastatic lymph node metastasis
2)The size of paraarotic lymph nodes detected by intraperative ultrasonography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
metastatic paraaortic lymph nodes size that is detectable by intraoperative ultrasonography
Key secondary outcomes
comparison the power intraoperative ultrasonography with other modalities
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
1 Gynecologic malignant patients who are planning systematic paraaortic lymph node dissection.
2.Necessity for informed consent
Key exclusion criteria
1. Having wish to preserve fertility
2.Inappropriate for this study by investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Itani |
Organization
Nara prefecture General Hosptal
Division name
Ob & Gyn
Zip code
Address
1-30-1 Hiramatsu Nara
TEL
0742-46-6001
yitani@nara-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Itani |
Organization
Nara prefectural Nara Hospital
Division name
Ob & Gyn
Zip code
Address
1-30-1 Hiramatsu Nara
TEL
0742-46-6001
Homepage URL
nuages@m3.kcn.ne.jp
Sponsor or person
Institute
Nara prefectural Nara Hospital Ob and Gyn
Institute
Department
Personal name
Funding Source
Organization
Nara prefectural Nara Hospital Ob and Gyn
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
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
奈良県総合医療センター（奈良県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 06 | 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
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
prospective case controlled study
Management information
Registered date
| 2011 | Year | 06 | Month | 06 | Day |
Last modified on
| 2016 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006775
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| Registered date | File name |
| Research case data | |
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