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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040450
Receipt No. 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 2020/05/19

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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 Mitsuhiro
Middle name
Last name Takenoyama
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
Email takenoyama.m@gmail.com

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
Email takamori@surg2.med.kyushu-u.ac.jp

Sponsor
Institute National Hospital Organization
Institute
Department

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
Email 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
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 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
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046168

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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