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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005729
Receipt No. 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

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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
Obsterics 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
Email 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
Email nuages@m3.kcn.ne.jp

Sponsor
Institute Nara prefectural Nara Hospital Ob and Gyn
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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