UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043063 |
|---|---|
| Receipt number | R000049169 |
| Scientific Title | Monitoring of TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade: A Biomarker Study. |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2021/01/20 15:26:25 |
* 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
Monitoring of TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade: A Biomarker Study.
Acronym
TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade
Scientific Title
Monitoring of TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade: A Biomarker Study.
Scientific Title:Acronym
TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade
Region
| Japan |
Condition
Condition
Treatment naive non-small cell lung cancer patients
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between the efficacy of pembrolizumab and TCR clonotype on CD8+PD-1+ T-cells
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between the efficacy of pembrolizumab and TCR clonotype on CD8+PD-1+ T-cells
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Treatment naive Advanced NSCLC patients.
2) Treatment with pembrolizumab.
3) Written Informed consent
Key exclusion criteria
1) Patients judged as inappropriate for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yoshida |
Organization
National Cancer Center Hospital
Division name
Department of thoracic oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
tatyoshi@ncc.go.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yoshida |
Organization
National Cancer Center Hospital
Division name
Department of thoracic oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
tatyoshi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Reserch 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
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
ncch-irb@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
| 2021 | Year | 01 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049169
