UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044535 |
|---|---|
| Receipt number | R000050879 |
| Scientific Title | A Biomarker Study Using Tumor-infiltrating Regulatory T Cells to Predict the Efficacy to Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer and Malignant Melanoma |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/06/16 20:26:01 |
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Basic information
Public title
A Biomarker Study Using Tumor-infiltrating Regulatory T Cells to Predict the Efficacy to Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer and Malignant Melanoma
Acronym
A Biomarker study of ICIs for non-small cell lung cancer and malignant melanoma
Scientific Title
A Biomarker Study Using Tumor-infiltrating Regulatory T Cells to Predict the Efficacy to Immune Checkpoint Inhibitors in Patients with Non-Small Cell Lung Cancer and Malignant Melanoma
Scientific Title:Acronym
A Biomarker study of ICIs for non-small cell lung cancer and malignant melanoma
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer or Malignant Melanoma
Classification by specialty
| Pneumology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between tumor-infiltrating T cells and the effect of ICI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine whether assessment of tumor-infiltrating PD-1 positive regulatory T cells (Treg) can be a predictive biomarker of ICI efficacy.
Key secondary outcomes
To determine whether other assessments in tumor-infiltrating T lymphocytes (TIGIT, LAG-3, CTLA-4, or other) are predictive biomarkers of ICI efficacy.
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. Patients with clinically significant suspicion of non-small cell lung cancer or malignant melanoma
2. Residual tissue from biopsies (or resections) performed for diagnostic purposes can be submitted
3. ICI is expected to be administered
4. Acquisition of written informed consent
Key exclusion criteria
None
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kiichiro |
| Middle name | |
| Last name | Ninomiya |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Hematology, Oncology and Respiratory Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama, Japan
TEL
086-235-7227
kiichiro_nino@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiichiro |
| Middle name | |
| Last name | Ninomiya |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Hematology, Oncology and Respiratory Medicine
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama, Japan
TEL
086-235-7227
Homepage URL
kiichiro_nino@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Hematology, Oncology and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2021 | Year | 09 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2021 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 03 | 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
Clinical efficacy by ICI (overall response rate, progression-free survival, overall survival, adverse events, or other)
Management information
Registered date
| 2021 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050879
