UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044536 |
|---|---|
| Receipt number | R000050858 |
| Scientific Title | Prospective observational study using novel predictors of efficacy of therapies including anti-PD-1/L1 antibodies for malignant tumors (non-small cell lung cancer, gastric cancer, esophageal cancer, renal cell carcinoma, urothelial carcinoma, malignant melanoma) |
| Date of disclosure of the study information | 2021/06/14 |
| Last modified on | 2023/07/04 11:08:28 |
* 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
Prospective observational study using novel predictors of efficacy of therapies including anti-PD-1/L1 antibodies for malignant tumors (non-small cell lung cancer, gastric cancer, esophageal cancer, renal cell carcinoma, urothelial carcinoma, malignant melanoma)
Acronym
Prospective observational study using novel predictors of efficacy of therapies including anti-PD-1/L1 antibodies for malignant tumors (non-small cell lung cancer, gastric cancer, esophageal cancer, renal cell carcinoma, urothelial carcinoma, malignant melanoma)
Scientific Title
Prospective observational study using novel predictors of efficacy of therapies including anti-PD-1/L1 antibodies for malignant tumors (non-small cell lung cancer, gastric cancer, esophageal cancer, renal cell carcinoma, urothelial carcinoma, malignant melanoma)
Scientific Title:Acronym
Prospective observational study using novel predictors of efficacy of therapies including anti-PD-1/L1 antibodies for malignant tumors (non-small cell lung cancer, gastric cancer, esophageal cancer, renal cell carcinoma, urothelial carcinoma, malignant melanoma)
Region
| Japan |
Condition
Condition
malignant tumors
Classification by specialty
| Gastroenterology | Pneumology | Dermatology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the immunological significance of the T cell cluster (CD4+ CD62Llow T cells) that constitutes the peripheral blood biomarker developed in the previous study.
Basic objectives2
Others
Basic objectives -Others
To explore novel peripheral blood biomarkers and evaluate whether they can be used to predict the efficacy of immune checkpoint inhibitor-based regimens for various malignancies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TCR repertoire analysis, identification of MHC-restricted antigens, methylome analysis, phosphorylation signaling pathway analysis, multi-color TIL analysis of tumor tissues, and single cell analysis of fresh tumor tissues will be performed using various peripheral immune cell fractions and collected tissues to analyze in detail the immunological significance of each immune cell cluster.
Key secondary outcomes
(1) To analyze the relationship between various clinical outcomes (ORR, PFS, OS, etc.) and peripheral blood biomarkers (discrimination formula* below).
* In PBMC, the discrimination formula is X2/Y, where X is the ratio of CD62Llow cells to CD4+ T cells and Y is the ratio of CD25+Foxp3+ cells.
2) Analyze the relationship between the various clinical outcomes and the newly identified peripheral immune cell subclusters and the expression of checkpoint molecules expressed on them.
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 aged 20 years or older at the time of obtaining consent
(2) Patients who have been fully informed of the contents of this study and have given their written consent.
3) PS0-2
4) Patients with an estimated prognosis of at least 3 months
5) Patients with evaluable lesions (measurable lesions are not required)
Additional criteria will be added for each type of carcinoma.
Key exclusion criteria
1) Patients with concurrent multiple cancers or heterogeneous multiple cancers with a disease-free interval of 5 years or less
* Patients with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that is judged to have been cured by local treatment are not excluded.
2) Patients with concomitant psychosis or psychiatric symptoms who are judged to have difficulty participating in the study
3) Patients who have received systemic administration of steroids within the last 4 weeks.
* The use of topical steroids is acceptable.
(4) Other patients who are judged inappropriate for participation in this study by the principal investigator or sub-investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kagamu |
Organization
Saitama Medical University International Medical Center, Comprehensive Cancer Center
Division name
Department of Respiratory Medicine
Zip code
350-1298
Address
Yamane 1397-1, Hidaka-city, Saitama
TEL
0429844581
kagamu19@saimata-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsuto |
| Middle name | |
| Last name | Mouri |
Organization
Saitama Medical University International Medical Center
Division name
Department of Respiratory Medicine
Zip code
350-1298
Address
Yamane 1397-1, Hidaka-city, Saitama
TEL
0429844111
Homepage URL
mouria@saitama-med.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
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
Saitama Medical University International Medical Center
Address
Yamane 1397-1, Hidaka-city, Saitama
Tel
0429844523
chikens@saitama-med.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 | 06 | Month | 14 | 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
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under registration
Management information
Registered date
| 2021 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050858
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
