UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045631 |
|---|---|
| Receipt number | R000052093 |
| Scientific Title | Evaluation of characteristics of cancer immunity by serum cytokines of breast cancer patients and search for stratification methods for drug treatment |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2023/10/04 17:05:55 |
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Basic information
Public title
Evaluation of characteristics of cancer immunity by serum cytokines of breast cancer patients and search for stratification methods for drug treatment
Acronym
Evaluation of characteristics of cancer immunity by serum cytokines of breast cancer patients and stratification
Scientific Title
Evaluation of characteristics of cancer immunity by serum cytokines of breast cancer patients and search for stratification methods for drug treatment
Scientific Title:Acronym
Evaluation of characteristics of cancer immunity by serum cytokines of breast cancer patients and stratification
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using stored samples (serum) of breast cancer patients participating in the "Tohoku University Hospital Personalized Medicine Center Biobank Division" (clinical biobank), the levels of thymic stromal lymphopoietin (TSLP) and cytokines with immunomodulatory activity will be determined. It will be investigated whether the levels of TSLP and specific cytokine suggest characteristics of cancer immunity in each patient, and whether they become biomarkers that contribute to the stratification of drug therapy.
Basic objectives2
Others
Basic objectives -Others
The characteristics of the immune responses against breast cancer will be predicted.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eighteen types of cytokines in stored serum samples (GM-CSF, IFN-gamma, IL-1beta, IL-2, IL-4, IL-5, IL-6, IL-8, IL-9, IL-10, IL-12p70, IL-17A, IL-17F, IL-22, IL-33, TNFalpha, TNF-beta, TSLP) are quantified all at once. The measurement results are collated with patient data (use of anticancer drug, stage, presence / absence / timing of metastasis, blood sampling time) to analyze the relationship with drug intractability.
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) Breast cancer patients whose specimens are stored in the Clinical Biobank, Biobank Division, Personalized Medicine Center, Tohoku University Hospital.
(2) The stage of cancer does not matter.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriyasu |
| Middle name | |
| Last name | Hirasawa |
Organization
Tohoku University
Division name
Graduate School of Pharmaceutical Sciences
Zip code
980-8578
Address
6-3 Aoba Aramaki, Aoba-ku, Sendai, Miyagi
TEL
022-795-6809
noriyasu.hirasawa.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriyasu |
| Middle name | |
| Last name | Hirasawa |
Organization
Tohoku University
Division name
Graduate School of Pharmaceutical Sciences
Zip code
980-8578
Address
6-3 Aoba Aramaki, Aoba-ku, Sendai, Miyagi
TEL
022-795-6809
Homepage URL
noriyasu.hirasawa.c7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
med-kenkyo@grp.tohoku.ac.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 | 10 | Month | 15 | 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
64
Results
TSLP in serum is associated with breast cancer more than the other cytokines.There was higher tendency toward higher TSLP levels with advanced pStage.
Results date posted
| 2023 | Year | 04 | Month | 03 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
The stored serum samples in Clinical biobank will be used. The measurement results are collated with patient data.
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052093
