臨床研究等提出・公開システム

Date of registration	July. 30, 2020
Last modified on	Sept. 01, 2020
Trial ID	jRCTs051200038

Scientific Title	Development of a new cancer diagnostic method based on metabolites derived from samples before and after oral administration of 13C-labeled glucose in patients with PET-positive lung cancer : Single-arm, exploratory clinical trial
Public Title	Search for new lung cancer biomarkers using 13C-labeled glucose

Contact for Scientific Queries	Name	Yoshida Masaru
	Affiliation	Kobe University Hospital
	Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-382-6305
	E-mail	myoshida@med.kobe-u.ac.jp
Contact for Public Queries	Name	Yoshida Masaru
	Affiliation	Kobe University Hospital
	Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-382-6305
	E-mail	myoshida@med.kobe-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 30, 2020
Actual date of first enrollment		Aug. 24, 2020
Target sample size		6
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who are at least 20 years old and under 80 years old at the time of obtaining consent (2) PET-positive primary lung cancer patients who can be surgically resected (3) Patients who have given their informed consent to participate in this clinical study
	Exclusion Criteria	(1) Patients with other cancers (2) Other patients judged inappropriate by the person in charge of this clinical study
	Age Minimum	20age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Resectable primary lung cancer
Intervention(s)		Administration of 13C glucose
Health Condition(s) Keyword		primary lung cancer
Primary Outcome(s)		Identification of derived metabolites in blood and urine after 13C glucose administration
Secondary Outcome(s)		Whether or not adverse events have occurred

Secondary Sponsor

Name of Certified Review Board	Kobe University Clinical Research Ethical Committee
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Telephone	+81-78-382-6669
E-Mail	cerb@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	June. 30, 2020

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 01, 2020	(this page)	Changes
1	July. 30, 2020	Detail

List of change history