UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060321 |
|---|---|
| Receipt number | R000069001 |
| Scientific Title | Multi-institutional retrospective observational study on the epidemiology of oligo disease and the significance of local therapy in advanced or recurrent thymic carcinoma (NEJ070) |
| Date of disclosure of the study information | 2026/01/13 |
| Last modified on | 2026/01/10 21:59:29 |
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Basic information
Public title
Multi-institutional retrospective observational study on the epidemiology of oligo disease and the significance of local therapy in advanced or recurrent thymic carcinoma (NEJ070)
Acronym
NEJ070
Scientific Title
Multi-institutional retrospective observational study on the epidemiology of oligo disease and the significance of local therapy in advanced or recurrent thymic carcinoma (NEJ070)
Scientific Title:Acronym
NEJ070
Region
| Japan |
Condition
Condition
Thymic carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the epidemiology of oligometastatic disease in advanced or recurrent thymic carcinoma to deepen our understanding of the disease, and to evaluate the clinical significance of local therapy in advanced and recurrent thymic carcinoma, thereby identifying the patient population that may benefit from local treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Epidemiological assessment
1) The prevalence of oligometastatic disease in patients with advanced or recurrent thymic carcinoma, as well as patterns of metastasis (metastatic organs and number of metastatic lesions)
2) The frequency and types of local therapy administered for oligometastatic disease
Prognostic evaluation
Overall survival (comparison between patients who received local therapy and those who did not)
Key secondary outcomes
Efficacy and safety of first line treatment
Progression free survival (PFS), objective response rate (ORR), disease control rate (DCR), and incidence of adverse events
In patients who underwent local therapy
Efficacy and safety of local therapy
PFS, ORR, DCR, and incidence of adverse events
Efficacy and safety of systemic therapy before and after local therapy
PFS, ORR, DCR, and incidence of adverse events
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
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included in the study
1) Thymic carcinoma confirmed by histological diagnosis.
2) Unresectable Masaoka stage III or higher disease, or recurrence after surgical resection and/or definitive (chemo)radiotherapy.
3) Advanced or recurrent disease diagnosed between April 1, 2000 and December 31, 2023.
4) Receipt of at least one of the following treatments: local therapy (palliative surgery or radiotherapy) and/or systemic chemotherapy.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study;
1) Cases deemed inappropriate for inclusion by the researchers.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takehito |
| Middle name | |
| Last name | Shukuya |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
113-8421
Address
3-1-3 Hongo Bunkyo-Ku Tokyo
TEL
03-3813-3111
tshukuya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Kataoka |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
s-kataoka@juntendo.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital Independent Ethics Committee
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.ac.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 | 01 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Retrospective Observational Study
Management information
Registered date
| 2026 | Year | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069001
