UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022409 |
|---|---|
| Receipt number | R000025828 |
| Scientific Title | Prospective study of embolization of thoracic wall artery for tumors of thoracic wall and pleura |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2019/10/02 11:29:22 |
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Basic information
Public title
Prospective study of embolization of thoracic wall artery for tumors of thoracic wall and pleura
Acronym
Prospective study of embolization of thoracic wall artery for thoracic wall tumors
Scientific Title
Prospective study of embolization of thoracic wall artery for tumors of thoracic wall and pleura
Scientific Title:Acronym
Prospective study of embolization of thoracic wall artery for thoracic wall tumors
Region
| Japan |
Condition
Condition
Malignant tumors of thoracic wall and pleura
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For malignant tumors of thoarcic wall or pleura, which can be hardly treated by surgery, radiation, and chemotherapy, feasibility and effectivenes of embolization of tumor feeding artery using NBCA are examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
1. Adverse event within one week of treatment
2. Antitumor effect within 3 months
Key secondary outcomes
1. Tumor shrinking period within 1 year
2. Local recurrence rate within 1 year
3. Prognosis in 3 years
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
NBCA is used during the embolization in less than 10ml.
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
| 1 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Malignant tumors of thoraci wall and pleura which can be hardly treated by surgery, radiation therapy, and chemotherapy.
2. Resectable tumors, which had better to be shrinked before surgery.
Key exclusion criteria
1
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nomori, MD |
Organization
Kameda Medical Center
Division name
Thoracic Surgery
Zip code
Address
929 Higashi-cho Kamogawa City, Chiba, 296-8602
TEL
0470-92-2211
hnomori@qk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nomori, MD |
Organization
Kameda Medical Center
Division name
Thoracic Surgery
Zip code
Address
929 Higashi-cho Kamogawa City, Chiba, 296-8602
TEL
0470-92-2211
Homepage URL
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 23 | 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
| 2016 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025828
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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