UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046871 |
|---|---|
| Receipt number | R000053469 |
| Scientific Title | A multicenter observational study to develop the program for predicting therapeutic efficacy of immune checkpoint inhibitor with OXEI (OXygen saturaion Endoscopic Imaging) |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2025/02/10 12:37:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multicenter observational study to develop the program for predicting therapeutic efficacy of immune checkpoint inhibitor with OXEI (OXygen saturaion Endoscopic Imaging)
Acronym
A multicenter observational study to develop the program for predicting therapeutic efficacy of immune checkpoint inhibitor with OXEI (OXygen saturaion Endoscopic Imaging)
Scientific Title
A multicenter observational study to develop the program for predicting therapeutic efficacy of immune checkpoint inhibitor with OXEI (OXygen saturaion Endoscopic Imaging)
Scientific Title:Acronym
A multicenter observational study to develop the program for predicting therapeutic efficacy of immune checkpoint inhibitor with OXEI (OXygen saturaion Endoscopic Imaging)
Region
| Japan |
Condition
Condition
esophageal cancer, gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a program to predict the therapeutic effect of ICI agents on gastrointestinal cancers using oxygen saturation imaging endoscopy (OXygen saturaion endoscopic imaging: OXEI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation analysis of OXEI with clinical course and clinicopathological features
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) gastric cancer, esophageal cancer
2) Those who are 20 years old or older at the time of obtaining informed consent
3) The patient who is going to receive an immune checkpoint inhibitor
4) The patients who have the primary tumor
5) Written informed consent has been obtained from the patient.
6) Consent has been obtained for the collection of tumor tissue and blood samples for research purposes.
Key exclusion criteria
Those who are deemed inappropriate by the investigator for some reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Yano |
Organization
national cancer center hospital east
Division name
Department of Gastroenterology and Endoscopy
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
81-4-7133-1111
toyano@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamashita |
Organization
national cancer center hospital east
Division name
Department of Gastroenterology and Endoscopy
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
81-4-7133-1111
Homepage URL
hiryamas@east.ncc.go.jp
Sponsor or person
Institute
national cancer center hospital east
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center hospital East, Ethical Review Support Section
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
81-4-7133-1111
IRBsupport@east.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
| 2022 | Year | 02 | Month | 08 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will collect information on the patient's age, gender, medical history, treatment history, blood test findings, endoscopic findings, imaging findings, and histopathology findings with electronic medical records at each medical facility.
In addition, additional tumor samples and blood samples will be collected with endoscopy and blood tests which are performed in routine clinical practice.
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053469
