UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046808 |
|---|---|
| Receipt number | R000053400 |
| Scientific Title | A multicenter retrospective observational study for pulmonary resection in pulmonary origometastasis after pancreatectomy |
| Date of disclosure of the study information | 2022/02/02 |
| Last modified on | 2024/02/05 15:29:58 |
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Basic information
Public title
A multicenter retrospective observational study for pulmonary resection in pulmonary origometastasis after pancreatectomy
Acronym
An observational study for pulmonary origometastasis after pancreatectomy
Scientific Title
A multicenter retrospective observational study for pulmonary resection in pulmonary origometastasis after pancreatectomy
Scientific Title:Acronym
JON2106-P
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the overall survival in patients with recurrent pulmonary origometastasis of pancreatic cancer received treatment including lung resection and only systemic chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Started the treatment for pulmonary metastasis before Dec. 31, 2020 in patients received radical resection (R0 or R1) for pancreatic cancer between Jan. 2009 and Dec. 2019.
2) Diagnosed as pancreatic ductal adenocarcinoma in reseced specimen.
3) Received chemotherapy or lung resection for only unilateral recurrent pulmonary metastasis .
Key exclusion criteria
1) Intraductal papillary mucinous carcinoma
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takahashi |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological Surgery
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL
+81-6-6945-1181
htakahashi@oici.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Takada |
Organization
Osaka International Cancer Institute
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL
+81-6-6945-1181
Homepage URL
ryoji.takada@oici.jp
Sponsor or person
Institute
Japan Oncology Network in Hepatobiliary and Pancreas
Institute
Department
Personal name
Funding Source
Organization
Japan Oncology Network in Hepatobiliary and Pancreas
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
Institutional Review Board of Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
Tel
+81-6-6945-1181
rinri01@opho.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
国立がん研究センター中央病院（東京都）
石川県立中央病院（石川県）
神奈川県立がんセンター（神奈川県）
大阪市立総合医療センター（大阪府）
聖隷浜松病院（静岡県）
兵庫県立がんセンター（兵庫県）
山口大学医学部附属病院（山口県）
金沢大学医学部付属病院（石川県）
高知医療センター（高知県）
新潟県立がんセンター新潟病院（新潟県）
北海道大学病院（北海道）
杏林大学医学部付属病院（東京都）
京都大学医学部付属病院（京都府）
山形大学医学部付属病院（山形県）
慶應義塾大学医学部付属病院（東京都）
聖マリアンナ医科大学病院（神奈川都）
大阪医療センター（大阪府）
香川大学医学部附属病院（香川県）
埼玉県立がんセンター（埼玉県）
国立国際医療研究センター病院（東京都）
大阪大学医学部付属病院（大阪府）
四国がんセンター（愛媛県）
宮崎大学医学部附属病院（宮崎県）
東北大学病院（宮城県）
千葉大学医学部附属病院（千葉県）
東京医科大学病院（東京都）
東京女子医科大学病院（東京都）
国立がん研究センター東病院（千葉県）
神戸大学医学部付属病院（兵庫県）
浜松医科大学医学部付属病院（静岡県）
静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 02 | 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
| 2021 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053400
