UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007583 |
|---|---|
| Receipt number | 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 15:57:42 |
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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
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
ueshin550621@gmail.com
Sponsor or person
Institute
First Dept. of Internal Medicine, Gifu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008956
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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