UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062265 |
|---|---|
| Receipt number | R000071251 |
| Scientific Title | Demographic and Clinical Characteristics, Treatment Patterns, and Clinical Outcomes Following Immune Checkpoint Inhibitor (ICI) Therapy in Patients with Endometrial Cancer, Gastric Cancer, or Advanced Non-Small Cell Lung Cancer in Japan |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/17 11:20:40 |
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Basic information
Public title
Demographic and Clinical Characteristics, Treatment Patterns, and Clinical Outcomes Following Immune Checkpoint Inhibitor (ICI) Therapy in Patients with Endometrial Cancer, Gastric Cancer, or Advanced Non-Small Cell Lung Cancer in Japan
Acronym
Demographic and Clinical Characteristics, Treatment Patterns, and Clinical Outcomes Following Immune Checkpoint Inhibitor (ICI) Therapy in Patients with Endometrial Cancer, Gastric Cancer, or Advanced Non-Small Cell Lung Cancer in Japan
Scientific Title
Demographic and Clinical Characteristics, Treatment Patterns, and Clinical Outcomes Following Immune Checkpoint Inhibitor (ICI) Therapy in Patients with Endometrial Cancer, Gastric Cancer, or Advanced Non-Small Cell Lung Cancer in Japan
Scientific Title:Acronym
Demographic and Clinical Characteristics, Treatment Patterns, and Clinical Outcomes Following Immune Checkpoint Inhibitor (ICI) Therapy in Patients with Endometrial Cancer, Gastric Cancer, or Advanced Non-Small Cell Lung Cancer in Japan
Region
| Japan |
Condition
Condition
Endometrial Cancer, Gastric Cancer, Non-Small Cell Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To describe the demographic and clinical characteristics and biomarker distributions of patients with the target diseases, as well as treatment patterns following immune checkpoint inhibitor (ICI) therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To describe the demographic and clinical characteristics and biomarker distributions of patients with the target diseases, as well as treatment patterns following immune checkpoint inhibitor (ICI) therapy.
Key secondary outcomes
To estimate clinical outcomes by line of therapy following immune checkpoint inhibitor (ICI) therapy in patients with the target diseases.
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.Diagnosed with at least one of the following target diseases during the study period:
･Endometrial cancer: Diagnosed between January 1, 2022 and December 31, 2024 (any stage; defined by ICD-10 code C54.1).
･Gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma (EAC): Diagnosed between January 1, 2018 and December 31, 2024 (ICD-10 codes: C15.X, C16.X).
･Lung cancer (ICD-10 codes: C34.X or C39.9) and pathologically confirmed as non-small cell lung cancer (NSCLC). Patients must have been diagnosed with advanced NSCLC between December 21, 2018 and December 31, 2024. The date of advanced NSCLC diagnosis is defined as the date of the initial NSCLC diagnosis for patients diagnosed at stage IIIB or IV.
2.A history of any of the following treatments for the target disease:
･Endometrial cancer: After diagnosis of endometrial cancer, patients must have received treatment with platinum agents (carboplatin or cisplatin) and immune checkpoint inhibitors (ICIs: pembrolizumab or durvalumab), administered in any sequence, either as monotherapy or in combination, and in any treatment setting (including neoadjuvant or adjuvant therapy), followed by at least one subsequent line of therapy.
･Gastric adenocarcinoma, GEJ adenocarcinoma, or EAC: A history of first-line treatment consisting of pembrolizumab or nivolumab in combination with chemotherapy for locally advanced unresectable or metastatic disease.
NSCLC: Since December 21, 2018, patients must have had at least one examination or treatment occurring >= 12 months after the last administration date of systemic anti-cancer therapy (SACT).
3.Age >= 18 years at the time of diagnosis of the target disease.
4.At least two clinical test results recorded in CyberOncology on separate dates on or after January 1, 2018.
Key exclusion criteria
1.Patients will be excluded if they have any of the following treatment histories:
･Endometrial cancer: Any record of systemic anti-cancer therapy (SACT) at any time within 90 days prior to the date of diagnosis of endometrial cancer.
･Gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma (EAC): Any history of SACT at any time within 90 days prior to the date of diagnosis of gastric adenocarcinoma, GEJ adenocarcinoma, or EAC.
･Non-small cell lung cancer (NSCLC): Any record of SACT at any time within 90 days prior to the date of diagnosis of NSCLC.
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Okada |
Organization
Prime Research Institute for Medical RWD, Inc.
Division name
Data Science Division
Zip code
606-8501
Address
Room 205, International Science Innovation Building, Kyoto University, 36-1 Yoshida-Honmachi, Sakyo-ku, Kyoto 606-8501 JAPAN
TEL
075-752-0330
masafumi.okada@ntt.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Okada |
Organization
Prime Research Institute for Medical RWD, Inc.
Division name
Data Science Division
Zip code
606-8501
Address
Room 205, International Science Innovation Building, Kyoto University, 36-1 Yoshida-Honmachi, Sakyo-
TEL
075-752-0330
Homepage URL
masafumi.okada@ntt.com
Sponsor or person
Institute
Prime Research Institute for Medical RWD, Inc.
Institute
Department
Personal name
Funding Source
Organization
Prime Research Institute for Medical RWD, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University
Name of secondary funder(s)
Kyoto University, MERCK & Co., INC.
IRB Contact (For public release)
Organization
MINS Institutional Review Board
Address
5-20-9-401 Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 07 | Month | 17 | 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
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study using registry data. The study will utilize data from the CONNECT2/J-CONNECT Registry, which includes 16 participating medical institutions led by Kyoto University Hospital. Eligible patients are those who were diagnosed with endometrial cancer, advanced or metastatic gastroesophageal adenocarcinoma, or non-small cell lung cancer between January 1, 2018, and May 31, 2026; were aged 18 years or older at the time of diagnosis; and had a history of treatment with an immune checkpoint inhibitor or systemic anticancer therapy.
Patients with a history of another malignancy before the diagnosis of the target cancer will be excluded.
Study variables will include systemic anticancer treatments, patient demographic and clinical characteristics, treatment patterns, tumor response, and other relevant clinical outcomes.
The study period will extend from the date of approval by the directors of the participating medical institutions through December 31, 2027.
Management information
Registered date
| 2026 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071251
