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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028699
Receipt No. R000032852
Scientific Title Difference in baseline risk assessment of postoperative recurrence between physicians and patients.
Date of disclosure of the study information 2017/08/17
Last modified on 2019/02/19

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Basic information
Public title Difference in baseline risk assessment of postoperative recurrence between physicians and patients.
Acronym Difference in baseline risk assessment between physicians and patients.
Scientific Title Difference in baseline risk assessment of postoperative recurrence between physicians and patients.
Scientific Title:Acronym Difference in baseline risk assessment between physicians and patients.
Region
Japan

Condition
Condition Primary invasive breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Verify whether any difference in the baseline risk assessment of postoperative recurrence between physicians and patients actually exists.
Basic objectives2 Others
Basic objectives -Others Difference in baseline risk assessment by physicians and patients in invasive breast cancer patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Difference in baseline risk assessment by physicians and patients in invasive breast cancer patients.
Key secondary outcomes 1.Difference in baseline risk assessment by physicians and patients by stage in all subtypes.
2.Difference in baseline risk assessment by physicians and patients by subtype in all stages.
3.Influence of patient's internal factors on difference in baceline risk assessment by physicians and patients.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent surgery for primary invasive breast cancer at Aichi Cancer Center Hospital.
Key exclusion criteria 1. Patients with noninvasive cancer.
2. Patients who underwent preoperative adjuvant therapy.
3. Patients who have difficultly trying to understand the concept of baseline risk of recurrence.
4. Patients who the doctor judged unsuitable for this study.
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makiko Mori
Organization Aichi Cancer Center Hospital
Division name Breast Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Email m.mori@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Mori
Organization Aichi Cancer Center Hospital
Division name Breast Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Homepage URL http://www.pref.aichi.jp/cancer-center/cc/01gaiy/rinri/
Email m.mori@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 17 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Verify whether any difference in the baseline risk assessment of postoperative recurrence between physicians and patients actually exists.

Management information
Registered date
2017 Year 08 Month 17 Day
Last modified on
2019 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032852

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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