UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049563 |
|---|---|
| Receipt number | R000056438 |
| Scientific Title | A multicenter cohort study of the effects of adjuvant treatments on cognitive functioning in older patients with breast cancer |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/20 12:35:16 |
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Basic information
Public title
A cohort study on cognitive functioning in older patients with breast cancer
Acronym
A cohort study on cognitive functioning in older patients with breast cancer
Scientific Title
A multicenter cohort study of the effects of adjuvant treatments on cognitive functioning in older patients with breast cancer
Scientific Title:Acronym
A multicenter cohort study of the effects of adjuvant treatments on cognitive functioning in older patients with breast cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Geriatrics | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study cognitive functioning in adjuvant treatments in older patients with breast cancer and to make a predict tool for the change of cognitive functioning.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of cognitive disorders
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Persons who participated in the study of 'Multicenter cohort study for development of comprehensive geriatric assessment screening tool in elderly breast cancer patients (UMIN000037454)'.
2) Persons who obtained written consent for participation in research
3) Age at the time of consent acquisition is over 70 years old
4) Those who have been diagnosed as "histologically primary breast cancer"
5) A person who can completely remove the visually identifiable lesion and does not have distant metastasis
6) Those who are scheduled to carry out the best treatment for breast cancer
Key exclusion criteria
1) Person who has serious organ dysfunction and cannot be radically resected
2) A person who has judged that incorporation into research is inappropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast Oncology
Zip code
464-8681
Address
Kanokoden 1-1, Chikusa-ku, Nagoya
TEL
052-762-6111
m-sawaki@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Department of Breast Oncology
Zip code
464-8681
Address
Kanokoden 1-1, Chikusa-ku, Nagoya
TEL
052-762-6111
Homepage URL
m-sawaki@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
KAKEN (21K07383)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
Kanokoden 1-1, Chikusa-ku, Nagoya
Tel
052-762-6111
irb-jimu@aichi-cc.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
| 2022 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
MMSE, MoCaJ, CAM are evaluated after 1 year, 3 years and 5 years after registration.
Management information
Registered date
| 2022 | Year | 11 | Month | 20 | Day |
Last modified on
| 2022 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056438
| 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 |
