UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049084 |
|---|---|
| Receipt number | R000055918 |
| Scientific Title | Multicenter prospective observational study of elderly functional assessment and sarcopenia assessment in patients over 75 years of age with resectable pancreatic cancer. |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/04/13 19:09:13 |
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Basic information
Public title
Multicenter prospective observational study of elderly functional assessment and sarcopenia assessment in patients over 75 years of age with resectable pancreatic cancer.
Acronym
Multicenter prospective observational study of elderly functional assessment and sarcopenia assessment in patients over 75 years of age with resectable pancreatic cancer.
Scientific Title
Multicenter prospective observational study of elderly functional assessment and sarcopenia assessment in patients over 75 years of age with resectable pancreatic cancer.
Scientific Title:Acronym
Multicenter prospective observational study of elderly functional assessment and sarcopenia assessment in patients over 75 years of age with resectable pancreatic cancer.
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
Evaluate the efficacy and safety of neoadjuvant chemotherapy in patients over 75 years of age with resectable pancreatic cancer. Explore the choice of regimen introduced and the relationship of safety and efficacy to functional assessment of the elderly and sarcopenia assessment.
Basic objectives2
Safety,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
| 75 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Clinically and radiologically consistent with resectable pancreatic cancer.
2) Patient is older than 75 years at the time of enrollment.
3) Patients have a histological diagnosis of cancer or suspected cancer, or a cytological diagnosis of class IV or V.
4) Diagnosed between December 1, 2022 and November 30, 2023.
5) No history of treatment for pancreatic cancer.
6)Able to perform elderly functional assessment and sarcopenia assessment.
7) The patient's informed consent has been obtained in writing.
8) No overlapping cancers under treatment.
Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Yokota |
Organization
Matsuyama Red Cross Hospital
Division name
Center for Liver-Biliary-Pancreatic Diseases
Zip code
790-8524
Address
1 Bumkyo-cho, Matsuyama City, Ehime
TEL
089-924-1111
yokota196@outlook.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Azemoto |
Organization
Matsuyama Red Cross Hospital
Division name
Center for Liver-Biliary-Pancreatic Diseases
Zip code
790-8524
Address
1 Bumkyo-cho, Matsuyama City, Ehime
TEL
089-924-1111
Homepage URL
azemotonobu@gmail.com
Sponsor or person
Institute
Ehime Pancreato-cholangiology [EPOCH] Study Group
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
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
Matsuyama Red Cross Hospital
Address
1 Bumkyo-cho, Matsuyama City, Ehime
Tel
089-924-1111
azemotonobu@gmail.com
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
愛媛大学附属病院（愛媛県）、愛媛県立中央病院（愛媛県）、市立宇和島病院（愛媛県）、松山赤十字病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective observational study of elderly functional assessment and sarcopenia assessment in patients over 75 years of age with resectable pancreatic cancer.
Management information
Registered date
| 2022 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055918
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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