UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046327 |
|---|---|
| Receipt number | R000052265 |
| Scientific Title | Retrospective observational study of association between geriatric assessment and prognosis in elderly gastrointestinal cancer patients |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2022/12/13 14:36:36 |
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Basic information
Public title
Retrospective observational study of association between geriatric assessment and prognosis in elderly gastrointestinal cancer patients
Acronym
Retrospective observational study of association between geriatric assessment and prognosis in elderly gastrointestinal cancer patients
Scientific Title
Retrospective observational study of association between geriatric assessment and prognosis in elderly gastrointestinal cancer patients
Scientific Title:Acronym
Retrospective observational study of association between geriatric assessment and prognosis in elderly gastrointestinal cancer patients
Region
| Japan |
Condition
Condition
Gastrointestinal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate G8 score and clinical outcomes in elderly gastrointestinal cancer patients at least 65 years old
Basic objectives2
Others
Basic objectives -Others
G8 score at the initial visit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
G8 score at the initial visit
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gastrointestinal cancer
Receiving G8 questionnaire at the initial visit
Key exclusion criteria
Noneligibility judged by principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Doi |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae0ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
adoi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinko |
| Middle name | |
| Last name | Hanaki |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae0ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
s.hanaki@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
St. Marianna University School of Medicine bioethics committee
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2021 | Year | 12 | Month | 10 | 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
207
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single institute retrospective observational study
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052265
| 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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