UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028301 |
|---|---|
| Receipt number | 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 16:18:39 |
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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
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
fnishi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university international medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031847
