Normally, clinical research is conducted after the research contents is explained to the patient in writing or orally and obtained their consent.
However, in accordance with the "Ethical Guidelines for Medical Research Involving Human Subjects," a guideline established by the government, clinical research that meets the following conditions does not necessarily require direct consent from each subject patient.
(1) Researches without invasion or intervention to the patient, such as those that only use patient's medical information
(2) Researches that use only surplus specimens
This method is called "opt-out". Even if this method is used, it is necessary to notify or disclose the purpose and implementation of the research, and to guarantee the opportunity to refuse participation as much as possible.
The following are the clinical research studies for which our organization implements the opt-out policy. If you do not want your data to be used for research purposes, please let us know by contacting the person listed below.
Medical researches conducted at CEMIT
| Title of research | An Integrated Analysis of Trifluridine/tipiracil hydrochloride (FTD/TPI) + Bevacizumab Treatment in Previously Treated Patients with Unresectable Advanced Recurrent Colorectal Cancer |
| Research period | August 1, 2020 - July 31, 2021 |
| Target cases | Patients who have participated in the following five studies: ・A Phase Ib /ll Clinical Trial of Concurrent Combination Therapy with TAS-102 and Bevacizumab in Patients with Unresectable or Recurrent Colorectal Cancer Refractory or Intolerant to Standard Chemotherapy ・A Phase Ib/ll Study of biweekly TAS-102 in Combination with Bevacizumab in Patients with Unresectable Advanced or Recurrent Colorectal Cancer Refractory to or Intolerant of Standard Chemotherapy ・Combination therapy of TAS-102 + bevacizumab for third-line treatment of unresectable or recurrent colorectal cancer ・A Phase II Study to Evaluate the Efficacy and Safety of TFTD (Lonsurf®) + Bevacizumab Combination Therapy with/without RAS Mutation in Patients with Unresectable Advanced or Recurrent Colorectal Cancer Refractory or Intolerant to Standard Chemotherapy ・A Phase II Study of TAS-102 (5-day oral therapy, 9-day rest) + Bevacizumab for Third-Line Treatment of Unresectable or Recurrent Colorectal Cancer |
| Research method | To collect data on patients from multiple phase II studies conducted in Japan to confirm the efficacy and safety of FTD/TPI + bevacizumab combination therapy, and conduct an integrated analysis of its safety and efficacy. |
| Types of specimen and information used for research | Specimen: None Information: Medical information such as background information, blood tests, presence of genetic mutations, past treatment history, etc. |
| Provision of specimens and information used for research to other institutions and its method | None |
| Handling of Personal Information | Since the data set used for analysis in this study does not include personal information such as the patient's medical record number or date of birth, the data set cannot be used to identify individuals, and it is assumed that there is no risk or disadvantage of personal information being leaked. The results of the research will be made available to the public in the form of conference presentations and publication of papers, but the disclosed information will not contain any personal information. |
| Chief Researcher | Kentaro Yamazaki, Department of Gastroenterology, Shizuoka Cancer Center |
| Contacts | The 22nd Century Cutting-Edge Medical IT Organization Jinbocho Towa Building. 8F, 2-13 Kanda Jimbo-cho, Chiyoda-ku, Tokyo 101-0051, Japan Office hours: 10:00-17:00 TEL: 03-6261-3569 Mail: info@22cemit.org |
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