Mie University Clinical Research Information Sheet

• May 27, 2016
• Reading time: 4 minutes

Introduction

This information sheet is a document from the Laboratory of Gene and Immune Cell Therapy, Mie University Graduate School of Medicine, requesting biological specimens for cancer immunology research (including genetic testing).

The content includes the consent procedure for patients and healthy volunteers. Please read carefully and evaluate thoroughly. After understanding and agreeing to the content, please sign and stamp the consent form. Declining to participate in this research will not result in any disadvantage or obstacle to your care whatsoever. The research you are being invited to participate in is: "Genetic testing and immune response analysis using clinical specimens."

Research Objectives

Mie University and affiliated research facilities are currently conducting various clinical trials related to cancer: "cancer vaccine clinical trials," "immune cell therapy," and "oncolytic virus therapy."

• Cancer vaccines: Reintroducing cancer-cell-specific antigens via injection to expand lymphocytes that destroy cancer cells within the body.
• Immune cell therapy: Extracting lymphocytes from blood samples, converting them into cancer-cell-attacking cells outside the body, expanding them, and reinfusing them.
• Oncolytic virus therapy: Administering viruses capable of dissolving (destroying) cancer cells.

All of these are promising new therapies. However, current cancer immunotherapy research is still in the stage of developing increasingly effective methods and accumulating scientific data to expand patient treatment options. This research aims to develop new treatments by investigating the immune status of cancer patients and healthy individuals, with the goal of potentially improving disease outcomes through a better understanding of patients' blood immune profiles in the future.

Additionally, this research investigates whether cancer antigens capable of being targeted by immunotherapy are present in patients' tumor tissue, to determine eligibility for immunotherapy. It also studies whether new tumor antigens could serve as targets for novel immunotherapies, and examines the quantity of cancer-cell-attacking lymphocytes in the blood and their actual efficacy against cancer cells.

Research Procedure

Specimens from this research — including tumor tissue and blood — will be sent to or received from collaborative research institutions nationwide (Keio University, University of Tokyo, Nagoya City University, University of Toyama, Osaka University, Kinki University, Okayama University, Kawasaki University of Medical Welfare, Yamaguchi University, and Kurume University).

Specimens requested:

1. Tumor tissue: Obtained during outpatient or inpatient visits, using tissue specimens from biopsies or surgical samples. Genetic material (RNA, DNA), proteins, and cancer antigens will be extracted. Where possible, lymphocytes extracted from tissue will be evaluated for their cancer-attacking capacity.
2. Blood samples: Drawn during outpatient or hospital visits. Used to assess lymphocyte blood type (HLA), evaluate the quantity and cancer-killing efficacy of lymphocytes, and measure cancer antigen antibody titers. Collected specimens will be stored for 15 years.

Risks

Tissue biopsies are obtained during endoscopic procedures for diagnosis or treatment. For this research, two additional small tissue samples may be collected beyond what is needed for diagnosis. Potential complications include bleeding at the biopsy site; however, because the specimens are very small, the bleeding risk is lower than standard biopsies. Any bleeding will be treated promptly and appropriately. Blood draws will only be performed if you do not have anemia or other abnormalities, and will not affect your future treatment.

Benefits and Limitations

The results of this research may not directly benefit you individually. However, they may be useful for assessing future eligibility for cancer immunotherapy. The research outcomes are expected to contribute to advances in medicine and future disease diagnosis and treatment.

Cost

All procedures are free of charge.

Privacy and Confidentiality

Your personal information will be protected. Your name and identifying details will be numerically coded and will not be identifiable in records or publications.

Specimen Storage

Biological specimens (DNA, RNA, serum, lymphocytes, etc.) obtained from you will be stored anonymously (personal data and specimens/data are cross-referenceable) until March 2029 at Mie University's Advanced Science Building and General Research Building (storage manager: Shin-ichi Kageyama, tel: 059-231-5187), after which they will be destroyed. This research involves collaboration with external institutions, and your specimens may be sent to other institutions for analysis and storage. Specimens will be destroyed after the planned storage period expires.

Right to Decline or Withdraw

You have the right to decide whether to participate in this research. You may withdraw at any time.

Contact

Research principal: Associate Professor Shin-ichi Kageyama, Laboratory of Gene and Immune Cell Therapy, Mie University Graduate School of Medicine (extension 5919, direct: 059-231-5187). Data management contact: Research staff member Tomoaki Nakamura (extension 5919, direct: 059-231-5187). Please contact us with any questions about this research.

Tags: #OncolyticVirus #LungCancer

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