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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Pulmonary Tumor | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kanazawa Medical University | ||||||
Division name | Thoracic Surgery | ||||||
Zip code | 920-0265 | ||||||
Address | Ishikawaken | ||||||
TEL | 0762862211 | ||||||
a2seki4@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kanazawa Medical University | ||||||
Division name | Thoracic Surgery | ||||||
Zip code | 920-0265 | ||||||
Address | Ishikawaken | ||||||
TEL | 0762862211 | ||||||
Homepage URL | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |