UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to assess an immune status in small cell lung cancer patients treated with cytotoxic chemotherapy
Title of the study (Brief title)	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	Fuyumi Nishihara
Organization	Saitama medical university international medical center
Division name	Respiratory Center
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	Fuyumi Nishihara
Organization	Saitama medical university international medical center
Division name	Respiratory Center
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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