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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039445
Receipt No. 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

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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 Obsterics 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
Email 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
Email akira-br@infoseek.jp

Sponsor
Institute Nagasaki university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044977

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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