UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021734 |
|---|---|
| Receipt number | R000025027 |
| Scientific Title | The prospective study of blood biomarker and gut microbiota in the patients treated with anti-PD 1 antibody for advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2020/03/08 11:07:11 |
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Basic information
Public title
The prospective study of blood biomarker and gut microbiota in the patients treated with anti-PD 1 antibody for advanced non-small cell lung cancer
Acronym
Biomarker study for nivolumab
Scientific Title
The prospective study of blood biomarker and gut microbiota in the patients treated with anti-PD 1 antibody for advanced non-small cell lung cancer
Scientific Title:Acronym
Biomarker study for nivolumab
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to elucidate plasma soluble PD-L1 or other biomaker in the advanced NSCLC patients treated with nivolumab.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate correlation between soluble PD-L1 or other biomarkers and clinical response or toxicities
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
Inclusion criterion of the present study is the patients who treated with chemotherapy at Komagome Hospital. Before being underwent chemotherapy, the patients examined blood sample with tube (or EDTA) contains sodium heparin of up to 14mL and/or fece.
Key exclusion criteria
Other than that above
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Okuma |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology and Respiratory Medicine
Zip code
113-8677
Address
Honkomagome 3-18-22, Bunkyo, Tokyo
TEL
03-3823-2101
y-okuma@cick.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Okuma |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology and Respiratory Medicine
Zip code
113-8677
Address
Honkomagome 3-18-22, Bunkyo, Tokyo
TEL
03-3823-2101
Homepage URL
y-okuma@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institut Gustave Roussy
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Tokyo Metropolitan Komagome Hospital
Address
3-28-22, Honkomagome, Bunkyo, Tokyo
Tel
03-3823-2101
rinri@cick.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
がん・感染症センター都立駒込病院（東京）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
We have already reported the result of soluble PD-L1 in non-small cell lung cancer demonstrated to be associated with poor prognosis. Therefore, we explore to detect biomarker including soluble PD-L1 or VEGF in the patients with nivolumab and investigate association with clinical outcome or characteristics.
Management information
Registered date
| 2016 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025027
