UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054288 |
|---|---|
| Receipt number | R000062005 |
| Scientific Title | A multi-institutional prospective observational study of incidence and risk factors for the development of osteosarcopenia in patients with unresectable pancreatic cancer receiving chemotherapy |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/05/02 10:25:51 |
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Basic information
Public title
A multi-institutional prospective observational study of incidence and risk factors for the development of osteosarcopenia in patients with unresectable pancreatic cancer receiving chemotherapy
Acronym
An observational study of incidence and risk factors for the development of osteosarcopenia in patients with unresectable pancreatic cancer receiving chemotherapy
Scientific Title
A multi-institutional prospective observational study of incidence and risk factors for the development of osteosarcopenia in patients with unresectable pancreatic cancer receiving chemotherapy
Scientific Title:Acronym
An observational study of incidence and risk factors for the development of osteosarcopenia in patients with unresectable pancreatic cancer receiving chemotherapy
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The relationship between osteosarcopenia and pancreatic cancer has not been fully investigated. In this study, we aimed to identify the incidence of osteosarcopenia and factors associated with its development by measuring changes in skeletal muscle mass and bone density over time in patients with unresectable pancreatic cancer undergoing chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Association between osteosarcopenia and prognosis of pancreatic cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative incidence of osteosarcopenia up to 12 months
Key secondary outcomes
The incidence of osteosarcopenia, the incidence of bone-related adverse events, the incidence of osteoporosis, the incidence of bone loss, the incidence of sarcopenia, the incidence of low trabecular bone score, overall survival, chemotherapy-induced adverse events, relative dose intensity, factors related to the incidence of osteosarcopenia (before chemotherapy, 6 and 12 months)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for chemotherapy for unresectable pancreatic invasive ductal adenocarcinoma.
Patients with pathologically diagnosed pancreatic invasive ductal adenocarcinoma.
Patients over 18 years old.
Informed consent obtained
Key exclusion criteria
Patients undergoing chemotherapy for pancreatic cancer prior to obtaining informed consent.
Patients deemed ineligible for the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhito |
| Middle name | |
| Last name | Koizumi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
0899645111
koizumim@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Ishikawa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
0899645111
Homepage URL
ishikawa.sho.nu@ehime-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Sho Ishikawa
Funding Source
Organization
None
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
Ehime University Hospital Clinical Therapeutic Trial Center
Address
454 Shitsukawa, Toon, Ehime, Japan
Tel
0899605914
cttc@m.ehime-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062005
