UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039445 |
|---|---|
| Receipt number | R000044977 |
| Scientific Title | Analysis of tumor antigen expression and immune response using clinical samples |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2020/02/10 13:15:29 |
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Basic information
Public title
Analysis of tumor antigen expression and immune response using clinical samples
Acronym
Analysis of tumor antigen expression and immune response
Scientific Title
Analysis of tumor antigen expression and immune response using clinical samples
Scientific Title:Acronym
Analysis of tumor antigen expression and immune response
Region
| Japan |
Condition
Condition
Gastrointestinal cancer, head and neck cancer, gynecological cancer, bone and soft tissue tumor, hematopoietic tumor, brain tumor, skin cancer, breast cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Breast surgery | Obstetrics and Gynecology |
| Dermatology | Orthopedics | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze and evaluate tumor antigen expression in tumor tissue and immune response including tumor localization in cancer patients, and to evaluate the efficacy in cancer immunotherapy such as T cell infusion therapy and cancer vaccine. Search for a biomarker that enhances
Basic objectives2
Others
Basic objectives -Others
This study could provide basic data for future clinical applications of immunotherapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression of tumor antigens in tissues (MAGE-A4, NY-ESO-1, CEA, GD2),
Analysis of tumor cells, immunocompetent cells, and cells involved in immunosuppression
Expression analysis of immune-related genes and genes related to immunosuppression
Analysis of immune reactions (humoral and cellular reactions)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1:From April 1, 2010 to March 31, 2025, at Nagasaki University Hospital and joint research facilities, gastrointestinal cancer, head and neck cancer, gynecological cancer, bone and soft tissue tumor, hematopoietic tumor, brain tumor, skin cancer, Patients who underwent a pathological examination at the time of diagnosis and who underwent pathological examination at the time of diagnosis and who obtained tissues such as ascites or peritoneal washings at the time of surgery
2:Patients who are 20 years old or older during the target period
3:Sex: gender does not matter
Patients who have received sufficient explanations before participating in this study and who have fully understood and obtained the written informed consent of the subject (or their sponsor) (patients who use residual samples Opt-out)
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Eguchi |
Organization
Nagasaki university
Division name
Department of Surgery
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki city
TEL
0958197316
akira-br@infoseek.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yoneda |
Organization
Nagasaki University
Division name
Department of Surgery
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki city
TEL
0958197316
Homepage URL
akira-br@infoseek.jp
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
Nagasaki university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
Sakamoto 1-7-1
Tel
0958197316
akira-br@infoseek.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
| 2020 | Year | 02 | Month | 14 | 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 | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From the medical records, the diagnosis, age at surgery, gender, and test results performed during surgery (blood tests, Collect all information on histopathological examination).
The following samples are used as samples.
Tumor specimen
Endoscopic biopsy tissue specimen (about 2 per case), or surgically removed tumor section, frozen tumor section (about 1 cm x 1 cm), pleural and ascites fluid. Specimens already collected (paraffin block samples) or biopsies and resections
Use the remaining sample at the time.
Blood (peripheral blood)
1) Typing of histocompatibility antigen molecules (HLA): 10 ml of blood collected.
2) ELISA of serum antibodies and cytokines against tumor antigens, Western blot analysis, etc .: Blood collection volume
8 ml.
3) Separation of CD8-positive cells and CD4-positive cells from lymphocytes, analysis of cell-mediated immunity against tumor antigens using ELISPOT method, flow cytometry, etc. after culturing: 20 ml of blood collection volume.
When giving the explanation, the blood collection volume is determined by referring to the hemoglobin value. When the hemoglobin value is 12 g / dL or less, the blood collection volume is 8 mL.
Management information
Registered date
| 2020 | Year | 02 | Month | 10 | Day |
Last modified on
| 2020 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044977
| Research Plan | |
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| 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 |
