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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042885
Receipt No. R000048947
Scientific Title Dynamic changes of immune-related molecules of peripheral blood in patients treated immunotherapy with advanced non-small cell lung cancer
Date of disclosure of the study information 2021/01/02
Last modified on 2021/01/02

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Basic information
Public title Dynamic changes of immune-related molecules of peripheral blood in patients treated immunotherapy with advanced non-small cell lung cancer
Acronym ICM-2 study
Scientific Title Dynamic changes of immune-related molecules of peripheral blood in patients treated immunotherapy with advanced non-small cell lung cancer
Scientific Title:Acronym ICM-2 study
Region
Japan

Condition
Condition Patients diagnosed with advanced non-small cell lung cancer (NSCLC: Non-Small-Cell-Lung-Cancer) scheduled to receive immunotherapy and combined immunotherapy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We measure soluble immune checkpoint molecules in peripheral blood of patients with advanced non-small cell lung cancer received immunotherapy. And we examine the relationship between them and clinical effects / toxicity, and examine whether they are candidates for biomarkers for predicting effects / toxicity and whether they are related to acquired tolerance.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We measured the dynamics of soluble immune checkpoint molecules, and observe clinical effect and observe toxicity, recurrence, and prognosis. Then evaluate their relevance.
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
20 years-old <
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with advanced non-small-cell lung cancer
Patients who are going to receive immunity checkpoint inhibitors
Written informed consent is obtained from all the patients.
Key exclusion criteria Patients having an overlap cancer with activity
Patients that an doctor judged to be inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Naruo
Middle name
Last name Yoshimura
Organization Tohoku Medical and Pharmaceutical University
Division name Division of Respiratory Medicine
Zip code 983-8536
Address 1-12-1, Komatsushima, Miyaginoku, Sendai, Miyagi 981-8558, JAPAN
TEL 0222908850
Email y-naruo@sc4.so-net.ne.jp

Public contact
Name of contact person
1st name Naruo
Middle name
Last name Yoshimura
Organization Tohoku Medical and Pharmaceutical University
Division name Division of Respiratory Medicine
Zip code 983-8536
Address 1-12-1, Komatsushima, Miyaginoku, Sendai, Miyagi 981-8558, JAPAN
TEL 0222908850
Homepage URL https://www.hosp.tohoku-mpu.ac.jp/center/cr_support_center/disclosure.html
Email y-naruo@sc4.so-net.ne.jp

Sponsor
Institute Tohoku Medical and Pharmaceutical University,Tohoku Medical and Pharmaceutical University Hospital
Institute
Department

Funding Source
Organization Tohoku Medical and Pharmaceutical University,Tohoku Medical and Pharmaceutical University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku Medical and Pharmaceutical University
Address 1-12-1, Komatsushima, Miyaginoku, Sendai, Miyagi 981-8558, JAPAN
Tel 022-259-1221
Email y-naruo@sc4.so-net.ne.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 02 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 09 Day
Date of IRB
2020 Year 12 Month 21 Day
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2021 Year 01 Month 02 Day
Last modified on
2021 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048947

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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