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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037454
Receipt No. 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 2020/06/09

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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 Okayama university hospital
Division name breast and endocrine surgery
Zip code 7008558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 862259657
Email ntaira@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Naruto
Middle name
Last name Taira
Organization Okayama university
Division name breast and endocrine surgery
Zip code 7008558
Address Shikata-cho 2-5-1
TEL 862259657
Homepage URL
Email ntaira@md.okayama-u.ac.jp

Sponsor
Institute Okayama university hospital
Institute
Department

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 Okayama university
Address Shikata-cho 2-5-1
Tel 862259657
Email ntaira@md.okayama-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
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
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042693

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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