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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007583
Receipt No. R000008956
Scientific Title Clinical impact of EUS and EUS-FNA of bilateral adrenal glands in patients with potentially resectable lung cancer
Date of disclosure of the study information 2012/04/01
Last modified on 2018/02/13

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Basic information
Public title Clinical impact of EUS and EUS-FNA of bilateral adrenal glands in patients with potentially resectable lung cancer
Acronym EUS-FNA of bilateral adrenal glands in lung cancer patients
Scientific Title Clinical impact of EUS and EUS-FNA of bilateral adrenal glands in patients with potentially resectable lung cancer
Scientific Title:Acronym EUS-FNA of bilateral adrenal glands in lung cancer patients
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Gastroenterology Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical impact of EUS and EUS-FNA of bilateral adrenal glands in potentially resectable lung cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To assess the detection rate of right adrenal gland by EUS and to compare the accuracy between CT, PET-CT and EUS/EUS-FNA for adrenal metastases.
Key secondary outcomes To compare the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) between CT, PET-CT and EUS/EUS-FNA for adrenal metastases.
To evaluate the incidence of EUS/EUS-FNA related complications.

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

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive patients with potentially resectable lung cancer who underwent EUS/EUS-FNA for staging of lung cancer at the Gifu University Hospital between October 2009 and September 2011.
Key exclusion criteria The exclusion criteria were patients with poor medical conditions of grades 4 and 5 according to the American Society of Anesthesiologists Physical Status classification system, and patients with bleeding
tendency and coagulopathy.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Yasuda
Organization Gifu University Hospital
Division name First Dept. of Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu 501-1194
TEL 058-230-6308
Email yasudaich@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Uemura
Organization Gifu University Hospital
Division name First Dept. of Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu 501-1194
TEL 058-230-6308
Homepage URL
Email ueshin550621@gmail.com

Sponsor
Institute First Dept. of Internal Medicine, Gifu University Hospital
Institute
Department

Funding Source
Organization First Dept. of Internal Medicine, Gifu University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Hospital Organization Nagara Medical Center
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 岐阜大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 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
2012 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We retrospectively collected the data of consecutive patients with potentially resectable lung cancer who underwent EUS/EUS-FNA for staging of lung cancer at the Gifu University Hospital between October 2009 and September 2011.

Management information
Registered date
2012 Year 03 Month 27 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008956

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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