臨床研究等提出・公開システム

Japanese

Date of registration	July. 08, 2020
Last modified on	Mar. 12, 2021
Trial ID	jRCT1032200065

Scientific Title	An observational study: the diagnostic feasibility using a new single-use cryoprobe for peripheral pulmonary lesions
Public Title	Diagnostic feasibility using a new cryoprobe for peripheral pulmonary lesions

Contact for Scientific Queries	Name	Tanaka Midori
	Affiliation	National Cancer Center Hospital
	Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
	Telephone	+81-3-3542-2511
	E-mail	midotana@ncc.go.jp
Contact for Public Queries	Name	Tanaka Midori
	Affiliation	National Cancer Center Hospital
	Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
	Telephone	+81-3-3542-2511
	E-mail	midotana@ncc.go.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 08, 2020
Actual date of first enrollment		July. 15, 2020
Target sample size		50
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients planning to undergo cryobiopsy for peripheral pulmonary lesions suspected of lung malignant neoplasms based on clinical signs and radiological images 2) Patients with a high-resolution CT scan performed within 1 month of the entry and the images fulfill the following three points i) A long diameter of 30 mm or less on the axial view ii) A solitary pulmonary nodule iii) A lesion locating beyond the subsegmental bronchus 3) Patients with no treatment history (i.e., surgery, radiation therapy, antitumor drugs, and so on) for the target lesion 4) Patients not younger than 20-year-old at the time of informed consent 5) Patients discontinuing anticoagulants and/or antiplatelet agents if used 6) Patients providing written informed consent
	Exclusion Criteria	1) Patients with a treatment history (i.e., surgery, radiation therapy, antitumor drugs, and so on) for the same side as the target lesion 2) Patients with a tracheostoma 3) Patients with poorly controlled mental disorders and/or dementia 4) Patients deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Lung neoplasms
Intervention(s)
Health Condition(s) Keyword		Lung neoplasms
Intervention(s) Keyword
Health Condition(s) Code		D008175
Intervention(s) Code
Primary Outcome(s)		diagnostic yield (sensitivity)
Secondary Outcome(s)		safety, specificity and accuracy, procedure duration, diagnostic yield by each sampling, microscopic evaluation for each tissue sample, diagnostic possibility by each tissue sample, and cumulative sensitivity

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail	ncch-irb@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	July. 01, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Mar. 12, 2021	(this page)	Changes
2	July. 17, 2020	Detail	Changes
1	July. 08, 2020	Detail

List of change history