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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031848
Receipt No. R000036367
Scientific Title peripheral marking with CT for Thoracoscopic surgery
Date of disclosure of the study information 2018/03/22
Last modified on 2021/02/08

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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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