UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059606 |
|---|---|
| Receipt number | R000063960 |
| Scientific Title | Epidemiological study of epNEC and LCNEC-L patients in Japan using the MASTER KEY Registry |
| Date of disclosure of the study information | 2025/10/31 |
| Last modified on | 2025/10/31 16:34:54 |
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Basic information
Public title
Epidemiological study of epNEC and LCNEC-L patients in Japan using the MASTER KEY Registry
Acronym
NEC patients in Japan (MASTER KEY Registry)
Scientific Title
Epidemiological study of epNEC and LCNEC-L patients in Japan using the MASTER KEY Registry
Scientific Title:Acronym
NEC patients in Japan (MASTER KEY Registry)
Region
| Japan |
Condition
Condition
extra-pulmonary neuroendocrine carcinoma (epNEC) and large cell neuroendocrine carcinoma of the lung (LCNEC-L)
Classification by specialty
| Pneumology | Endocrinology and Metabolism | Neurology |
| Chest surgery | Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Among patients with epNEC and LCNEC-L in the MASTER KEY Registry Database, to describe:
A) Patient demographics, clinical characteristics and biomarkers
B) Treatment status at each line of pharmacotherapy (LOP)
C) Treatment outcomes by each LOP and each treatment regimen
- Real-world objective response rate [rwORR]
- Real-world disease control rate [rwDCR]
- Real-world overall survival [rwOS]
- Real-world progression free survival [rwPFS]
- Real-world time to next treatment [rwTTNT]
Basic objectives2
Others
Basic objectives -Others
Epidemiological study using the MASTERKEY database and testing delta-like ligand 3 (DLL3) expression of patient
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
A) Patient demographics, clinical characteristics and biomarkers
B) Treatment status at each LOP
C) Treatment outcomes by each LOP
- rwORR
- rwDCR
- rwOS
- rwPFS
- rwTTNT
Key secondary outcomes
- DLL3 expression status
- Treatment outcomes by DLL3 expression status
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
1) Patients who gave a written consent to the MASTER KEY Registry (NCCH1612) and were enrolled in it
2) Clinical diagnosis of epNEC or LCNEC-L
3) Patients with any records of pharmacotherapy
Key exclusion criteria
None.
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Hana |
| Middle name | |
| Last name | Kimura |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Real World Evidence Japan
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
070-2674-6485
hana.kimura@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Hana |
| Middle name | |
| Last name | Kimura |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Real World Evidence Japan
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
070-2674-6485
Homepage URL
hana.kimura@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511
irst@ml.res.ncc.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
| 2025 | Year | 10 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
- A non-interventional/observational, cohort study using existing data (the MASTERKEY Registry Database).
- The MASTERKEY database enrollment began on May 1, 2017, and this study will use data up to July 31, 2024.
- This study aims to enhance our understanding of the epidemiology of epNEC and LCNEC-L in Japan, including the patient characteristics, treatment status, clinical outcomes, and DLL3 expression status.
Management information
Registered date
| 2025 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063960
