UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039813 |
|---|---|
| Receipt number | R000045402 |
| Scientific Title | A prospective observational study of Comprehensive Geriatric Assessment in elderly patients with pancreaticobiliary cancer who receive chemotherapy |
| Date of disclosure of the study information | 2020/03/16 |
| Last modified on | 2023/02/26 21:53:26 |
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Basic information
Public title
A prospective observational study of Comprehensive Geriatric Assessment in elderly patients with pancreaticobiliary cancer who receive chemotherapy
Acronym
A prospective observational study of Comprehensive Geriatric Assessment in elderly patients with pancreaticobiliary cancer who receive chemotherapy
Scientific Title
A prospective observational study of Comprehensive Geriatric Assessment in elderly patients with pancreaticobiliary cancer who receive chemotherapy
Scientific Title:Acronym
A prospective observational study of Comprehensive Geriatric Assessment in elderly patients with pancreaticobiliary cancer who receive chemotherapy
Region
| Japan |
Condition
Condition
pancreaticobiliary cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relevance of treatment outcomes and the scores of Comprehensive Geriatric Assessment (CGA) for patients with pancreaticobiliary cancer aged 70 years or over who receive or plan to receive chemotherapy
Basic objectives2
Others
Basic objectives -Others
To investigate what tools could predict appropriate regimens for elderly patients, and the efficacy and safety of chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evalutaion of what tools are effective to decide treatment and to predict efficacy and safety of chemotherapy
Key secondary outcomes
Relation to the scores of CGA and as follows; Overall survival, Progression free survival, duration of treatment, adverse event
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable or reccurent pancreaticobiliary cancer
Patients aged 70 years or over when they provide consent
Patients who receive or plan to receive chemotherapy
Patients with written informed consent
Key exclusion criteria
Patients considered inappropriate for participation by the attending physician
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
Graduate School of Medicine, The Tokyo University
Division name
Department of Endoscopy and Endoscopic Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
ynakai-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate School of Medicine, The Tokyo University
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
yukasuzuki-tuk@umin.ac.jp
Sponsor or person
Institute
The Tokyo University
Institute
Department
Personal name
Funding Source
Organization
The Tokyo University
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
Department of Gastroenterology, Graduate School of Medicine, The Tokyo University
Address
7-3-1, Hongo Bukyo-ku, Tokyo, Japan
Tel
03-3815-5411
yukasuzuki-tuk@umin.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2019141NI
Org. issuing International ID_1
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 16 | 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
123
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
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the relevance of treatment outcomes and the scores of Comprehensive Geriatric Assessment (CGA) for patients with pancreaticobiliary cancer aged 70 years or over who receive or plan to receive chemotherapy
Management information
Registered date
| 2020 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045402
