UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042885 |
|---|---|
| Receipt number | 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 14:19:08 |
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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
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
y-naruo@sc4.so-net.ne.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University,Tohoku Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048947
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
