UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001725 |
|---|---|
| Receipt number | R000002077 |
| Scientific Title | Mediastinal lymph node staging in lung cancer: A prospective comparison of CT/FDG-PET and EUS-FNA/EBUS-TBNA |
| Date of disclosure of the study information | 2009/03/01 |
| Last modified on | 2010/08/25 08:10:38 |
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Basic information
Public title
Mediastinal lymph node staging in lung cancer: A prospective comparison of CT/FDG-PET and EUS-FNA/EBUS-TBNA
Acronym
Combined approach of EUS-FNA and EBUS-TBNA in mediastinal nodal staging of lung cancer
Scientific Title
Mediastinal lymph node staging in lung cancer: A prospective comparison of CT/FDG-PET and EUS-FNA/EBUS-TBNA
Scientific Title:Acronym
Combined approach of EUS-FNA and EBUS-TBNA in mediastinal nodal staging of lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of combined approach of EUS-FNA and EBUS-TBNA for N-stage in patients with lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
To compare the accuracy of CT/FDG-PET and EUS-FNA/EBUS-TBNA
Key secondary outcomes
Incidence of EUS-FNA/EBUS-TBNA related complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
CT, FDG-PET, EUS-FNA and EBUS-TBNA are performed in patients with lung cancer
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
1.Patients with newly diagnosed or suspected lung cancer based on CT and bronchoscopic findings
2.The clinical stage is judged to be below T4, any N, M0 according to TNM subsets (UICC)
3.Patients obtained written informed consent
Key exclusion criteria
1.Patients with poor medical conditions of grade-4 and -5, according to ASA classification)
2.Patients with bleeding tendency and coagulopathy
3.Case in which the patient refused surgery
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu 501-1194
TEL
058-230-6308
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido, 501-1194
TEL
058-230-6308
Homepage URL
YASUDAIC@aol.com
Sponsor or person
Institute
First Department of Internal Medicine, Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | 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
| 2009 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 22 | Day |
Last modified on
| 2010 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002077
