UMIN-CTR Clinical Trial

Basic information
Public title	peripheral marking with CT for Thoracoscopic surgery
Acronym	Peripheral marking for TS
Scientific Title	peripheral marking with CT for Thoracoscopic surgery
Scientific Title:Acronym	Peripheral marking for TS
Region	Japan

Condition
Condition	Pulmonary Tumor
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Before surgery, peripheral marking is performed above the tumor using CT and whether or not marking on the visceral pleurum just above the tumor is examined during the subsequent surgery is examined.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Distance between the marking site on the lung surface and the actual center of the tumor.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	CT guide direct skin marking of the tumor
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Primary lung cancer (bronchoscopic lung biopsy or intraoperative rapid test) or suspected Metastatic lung tumor Tumor size up to 2 cm. The distance from the lung surface is 2 cm or less. Partial resection is planned. (As a result of pathological diagnosis, cases involving lung lobectomy are included) 20-85 years old Indication of whole body condition: Performance Status (ECOG) 0 or 1 Related major organ function Following a sufficient informed consent to participate in this study, the patient consent was obtained with the free will of the patient himself / herself
Key exclusion criteria	Patient who does not need to judge localization of tumor intraoperatively (patient planning to perform lobectomy from the beginning) Case in which marking of the wall side pleura is expected to be difficult after marking the body surface, such as when there is a lesion on the back side of the shoulder blades or there is a lesion on the longitudinal side
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Sekimura
Organization	Kanazawa Medical University
Division name	Thoracic Surgery
Zip code	920-0265
Address	Ishikawaken
TEL	0762862211
Email	a2seki4@yahoo.co.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Sekimura
Organization	Kanazawa Medical University
Division name	Thoracic Surgery
Zip code	920-0265
Address	Ishikawaken
TEL	0762862211
Homepage URL
Email	a2seki4@yahoo.co.jp

Sponsor
Institute	Kanazawa Medical University Department of thoracic surgery
Institute
Department

Funding Source
Organization	Kanazawa Medical University, Department of Thoracic Surgery
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanazawa medical university
Address	1-1 Daigaku, Uchinadacho, Kahokugun
Tel	0762862211
Email	tiken@kanazawa-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	金沢医科大学病院　呼吸器外科

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 Month 10 Day
Date of closure to data entry	2019 Year 01 Month 20 Day
Date trial data considered complete	2019 Year 01 Month 30 Day
Date analysis concluded	2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 22 Day
Last modified on	2021 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036367

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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