UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037454 |
|---|---|
| Receipt number | R000042693 |
| Scientific Title | Multicenter cohort study for development of comprehensive geriatric assessment screening tool in elderly breast cancer patinets |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2023/01/04 18:34:34 |
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Basic information
Public title
Cohort study of elderly breast cancer patients
Acronym
Cohort study of elderly breast cancer patients
Scientific Title
Multicenter cohort study for development of comprehensive geriatric assessment screening tool in elderly breast cancer patinets
Scientific Title:Acronym
Multicenter cohort study for development of comprehensive geriatric assessment screening tool in elderly breast cancer patinets
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is validation study of the CGA screening tool developed from the previous research
Basic objectives2
Others
Basic objectives -Others
In this study, we examine whether the RESPECT model is useful for predicting the prognosis of elderly breast cancer patients as well as predicting the risks and benefits associated with treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
Overall survival, adverse events, treatment compliance
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
1) Persons who obtained written consent for participation in research
2) Age at the time of consent acquisition is over 70 years old
3) Those who have been diagnosed as "histologically primary breast cancer"
4) A person who can completely remove the visually identifiable lesion and does not have distant metastasis
5) Those who are scheduled to carry out the best treatment for breast cancer
Key exclusion criteria
1) Person who has serious organ dysfunction and can not be radically resected
2) A person who has judged that incorporation into research is inappropriate
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Kawasaki Medical College
Division name
Breast and Thyroid Surgery
Zip code
7010192
Address
Matsushima 577, Kurashiki city, Okayama
TEL
0864621111
ntaira@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Kawasaki Medical College
Division name
Breast and Thyroid Surgery
Zip code
7010192
Address
Matsushima 577, Kurashiki city, Okayama
TEL
0864621111
Homepage URL
ntaira@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical College
Institute
Department
Personal name
Funding Source
Organization
NPO Setouschi breast project
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
81:JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical College
Address
Matsushima 577, Kurashiki city, Okayama
Tel
0864641076
kmsrec@med.kawasaki-m.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
| 2019 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter cohort study
Management information
Registered date
| 2019 | Year | 07 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042693
| 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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| Registered date | File name |
