臨床研究等提出・公開システム

Date of registration	April. 03, 2026
Last modified on	April. 03, 2026
Trial ID	jRCT1030260016

Scientific Title	An observational study to verify the safety and effectiveness of treatment using organic iodine + MD(alpha) for patients with advanced cancer (stage 3 or later) using standard and advanced test indicators
Public Title	An observational study to verify the safety and effectiveness of treatment using organic iodine + MD(alpha) for patients with advanced cancer (stage 3 or later) using standard and advanced test indicators

Contact for Scientific Queries	Name	Shirakawa Taro
	Affiliation	Kisaragi Soken Clinic
	Address	5F, 1-32-14 Onanuki, Minami-ku, Fukuoka City, Fukuoka Prefecture
	Telephone	+81-92-406-4141
	E-mail	cro@jscsf.net
Contact for Public Queries	Name	Kobayashi Hideo
	Affiliation	Japan Society of Clinical Study for Frontier-Medicine
	Address	1-8-16-6F Yaesu, Chuo-ku, Tokyo
	Telephone	+81-3-5542-1597
	E-mail	cro@jscsf.net

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 03, 2026
Target sample size		10
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	A case in which organic iodine + MD(alpha) was used in a patient who was not responding to standard drugs
	Exclusion Criteria	1) Patients who were unable to continue due to hypersensitivity or allergic reactions to organic iodine + MD(alpha) 2) Patients who are taking other drugs concomitantly, or patients who have previously participated in clinical trials and have not yet been on the last dose of the test drug for more than one month 3) Patients who are otherwise deemed inappropriate by the principal investigator or co-investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cancer
Health Condition(s) Keyword		Cancer
Health Condition(s) Code		D009369
Primary Outcome(s)		TC test, cell-free test, tumor marker, various imaging tests (PET-CT, MRI, etc.), appearance and morphological changes, self-reporting, and doctor's findings
Secondary Outcome(s)		Adverse event rates were measured using CTCAE

Primary Sponsor	none

Name of Certified Review Board	JSCSF-CRB
Address	1-8-16 Yaesu, Chuo-ku, Tokyo
Telephone	+81-3-5542-1597
E-Mail	mail@jscsf.net
Approval Status	Approval
Date of approval	Nov. 30, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none