UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040450 |
|---|---|
| Receipt number | R000046168 |
| Scientific Title | Prospective Observational Study of Nutritional/Immunologic Indices as Predictive Biomarkers to Anti-PD-1 Drugs in Non-small-Cell Lung Cancer |
| Date of disclosure of the study information | 2020/05/21 |
| Last modified on | 2023/11/21 10:12:21 |
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Basic information
Public title
Prospective Observational Study of Nutritional/Immunologic Indices as Predictive Biomarkers to Anti-PD-1 Drugs in Non-small-Cell Lung Cancer
Acronym
ICI-PREDICT study
Scientific Title
Prospective Observational Study of Nutritional/Immunologic Indices as Predictive Biomarkers to Anti-PD-1 Drugs in Non-small-Cell Lung Cancer
Scientific Title:Acronym
ICI-PREDICT study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study is to investigate the clinical impact of pre-treatment nutritional/immunologic indices on the outcomes of patients with advanced non-small cell lung cancer who are treated with immune checkpoint inhibitors. The relationship between early post-treatment changes in nutritional/immunologic indices and outcomes will also be analyzed in the study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival
Response rate
Disease control rate
Cancer-specific progression-free survival
Cancer-specific overall survival
Safety
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
･Pathologically confirmed non-small cell lung cancer (cytology or histology)
･Available programmed cell death-ligand 1 expression on tumor cells (tumor proportion score)
･Any target lesions designated by Response Evaluation Criteria in Solid Tumors version 1.1
･Minimum age of 20 years old
･Stage IV disease or Stage III disease not applicable for definitive chemoradiotherapy
･Treatment with checkpoint inhibitors (monotherapy or combined with chemotherapy) as 1st line therapy
･Written informed consent from the patient
Key exclusion criteria
･Any oncogene mutation (epidermal growth receptor factor, anaplastic lymphoma kinase, c-ros oncogene 1, RET, BRAF)
･Difficulty in evaluating pre-treatment nutritional/immunologic
･Active other kind of cancer
･Active infection with HIV, hepatitis B, or hepatitis C virus
･History of cancer immunotherapy
･Considered to be unsuitable for enrolment by the investigator's judgment
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Thoracic Oncology
Zip code
811-1395
Address
3-1-1, Notame, Minami-ku, Fukuoka
TEL
092-541-3231
yamaguchi.masafumi.wb@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Takamori |
| Middle name | |
| Last name | Shinkichi |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Thoracic Oncology
Zip code
811-1395
Address
3-1-1, Notame, Minami-ku, Fukuoka
TEL
092-541-3231
Homepage URL
shinkichi.takamori@gmail.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Central Review Board
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.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
| 2020 | Year | 05 | Month | 21 | 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
305
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
| 2019 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Observational Study of Nutritional/Immunologic Indices as Predictive Biomarkers to Anti-PD-1 Drugs in Non-small-Cell Lung Cancer
Management information
Registered date
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046168
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| Registered date | File name |
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| Registered date | File name |
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