臨床研究等提出・公開システム

Date of registration	Feb. 01, 2022
Last modified on	Feb. 01, 2022
Trial ID	jRCT1070210123

Scientific Title	Dynamic assessment of elderly cancer patients
Public Title	Dynamic assessment of elderly cancer patients

Contact for Scientific Queries	Name	Yoshida Yoichiro
	Affiliation	Fukuoka University Hospital
	Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
	Telephone	+81-92-801-1011
	E-mail	yyoshida@fukuoka-u.ac.jp
Contact for Public Queries	Name	Yoshida Yoichiro
	Affiliation	Fukuoka University Hospital
	Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
	Telephone	+81-92-801-1011
	E-mail	yyoshida@fukuoka-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 08, 2021
Actual date of first enrollment		Oct. 06, 2021
Target sample size		20
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who have been histologically diagnosed with cancer (patients who have not undergone surgery for cancer within 5 years) 2) Patients who are scheduled to undergo surgery for cancer at Fukuoka University Hospital 3) Age 65 years or older at the time of obtaining consent 4) Patients whose written consent has been obtained from the patient
	Exclusion Criteria	1) Patients who are unable to move on their own 2) Patients who are judged by the research physician to be inappropriate for this study
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cancer
Health Condition(s) Code		D009369
Primary Outcome(s)		Mobile sensor detection rate
Secondary Outcome(s)		(1) Mobile sensor attachment rate (2) Validity of data acquisition method (3) Length of hospital stay (4) Postoperative complications (Clavien-dindo classification) (5) Period to bed release (6) ASA-PS (American Society of Anesthesiologists' risk classification of anesthesia according to the health status of the patient) (7) NYHA (Determination of the severity of heart failure) (8) Hugh-Jones classification (criteria for evaluating the severity of respiratory disease in terms of motor function and dyspnea)

Primary Sponsor	M3, Inc.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Fukuoka University Hospital Institutional Review Board
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka
Telephone	+81-92-801-1011-3193
Approval Status	Approval
Date of approval	July. 08, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none