UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060892 |
|---|---|
| Receipt number | R000069577 |
| Scientific Title | The diagnostic yield of malignant lymphoma by convex-probe endobronchial ultrasound bronchoscope: a multicenter prospective observational study |
| Date of disclosure of the study information | 2026/03/11 |
| Last modified on | 2026/03/11 02:32:30 |
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Basic information
Public title
The diagnostic yield of malignant lymphoma by convex-probe endobronchial ultrasound bronchoscope: a multicenter prospective observational study
Acronym
The diagnostic yield of malignant lymphoma by convex-probe endobronchial ultrasound bronchoscope: a multicenter prospective observational study
Scientific Title
The diagnostic yield of malignant lymphoma by convex-probe endobronchial ultrasound bronchoscope: a multicenter prospective observational study
Scientific Title:Acronym
The diagnostic yield of malignant lymphoma by convex-probe endobronchial ultrasound bronchoscope: a multicenter prospective observational study
Region
| Japan |
Condition
Condition
Malignant lymphoma
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effective methods and equipments for endobronchial ultrasound-guided biopsy targeting hilar/mediastinal lymph nodes or hilar/mediastinal lesions in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calculation of diagnostic yields for each method with endobronchial ultrasound bronchoscope for hilar and mediastinal lesions and hilar and mediastinal lymph node.
Key secondary outcomes
1. Evaluation of diagnostic yields by biopsy devises
2. Evaluation of adverse events associated with biopsies
3. Evaluation of the relationship between diagnostic yields and flow cytometry
4. Evaluation of the relationship between diagnostic yields and rapid on-site cytological evaluation (ROSE)
5. Evaluation of the relationship between diagnostic yields and the number of biopsies and tissue specimens
6. Evaluation of the relationship between target lesion sizes and diagnostic yields
7. Evaluation of diagnostic yields for EBUS-TBNA alone versus EBUS-TBNA preceded by EBUS-IFB/MFB or EBUS-TMC
8. Evaluation of diagnostic yields for EBUS-TBNA alone versus the combined diagnostic yields of EBUS-TBNA with EBUS-IFB/MFB and EBUS-TMC
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with hilar/mediastinal lesions and/or lymph nodes, where malignant lymphoma lesions are considered.
2. 18 years or older
3. Informed consent
Key exclusion criteria
1. Patients who are already diagnosed malignant lymphoma pathologically by other lesions.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Oki |
Organization
NHO Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1, Sannomaru, Naka-ku, Nagoya city, Aichi, Japan
TEL
052-951-1111
masahideo@aol.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Torii |
Organization
NHO Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1, Sannomaru, Naka-ku, Nagoya city, Aichi, Japan
TEL
052-951-1111
Homepage URL
a51009068@gmail.com
Sponsor or person
Institute
Central Japan Lung Study Group
Institute
Department
Personal name
Funding Source
Organization
NHO Nagoya Medical Center
Central Japan Lung Study Group
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
the Institutional Review Board of Nagoya Medical Center
Address
4-1-1 Sannomaru, Naka-ku, Nagoya city, Japan
Tel
052-951-1111
311-rec@mail.hosp.go.jp
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
| 2026 | Year | 03 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
| 2029 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2029 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2030 | Year | 09 | Month | 11 | Day |
Other
Other related information
Prospective consecutive study
Six months after the biopsy, we will check patient characteristics and the details how to perform biopsies if the patients were diagnosed malignant lymphoma.
Management information
Registered date
| 2026 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069577
