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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028301
Receipt No. R000031847
Scientific Title Study to assess an immune status in small cell lung cancer patients treated with cytotoxic chemotherapy
Date of disclosure of the study information 2017/07/20
Last modified on 2017/07/20

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Basic information
Public title Study to assess an immune status in small cell lung cancer patients treated with cytotoxic chemotherapy
Acronym Study to assess an immune status in small cell lung cancer patients treated with cytotoxic chemotherapy
Scientific Title Study to assess an immune status in small cell lung cancer patients treated with cytotoxic chemotherapy
Scientific Title:Acronym Study to assess an immune status in small cell lung cancer patients treated with cytotoxic chemotherapy
Region
Japan

Condition
Condition small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify T cell immune balance in small
cell lung cancer patients treated with cytotoxic chemotherapy with new biomarkers we found in non-small lung cancer patients treated with anti-PD-1 mAb.
Basic objectives2 Others
Basic objectives -Others others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To examine T cell balance with
flow cytometry. Samples should be collected at four points, pretreatment, mid-treatment (2 and 3 or 4 weeks) and post-treatment 3 to 4 weeks later.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who are planned to be treated with chemotherapy.
2. Written study-specific informed consent.
Key exclusion criteria 1. The patients who are difficult to entry to this study because of psychological disorders.
2. The patients who are judged to be unsuitable by doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuyumi Nishihara
Organization Saitama medical university international medical center
Division name Respiratory Center
Zip code
Address 1397-1, Yamane, Hidaka-City, Saitama-Pref
TEL +81-42-984-4111
Email fnishi@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fuyumi Nishihara
Organization Saitama medical university international medical center
Division name Respiratory Center
Zip code
Address 1397-1, Yamane, Hidaka-City, Saitama-Pref
TEL +81-42-984-4111
Homepage URL
Email fnishi@saitama-med.ac.jp

Sponsor
Institute Saitama medical university international medical center
Institute
Department

Funding Source
Organization MEXT/JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 Month 20 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
2017 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2017 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031847

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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