UMIN-CTR Clinical Trial

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