UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028699 |
|---|---|
| Receipt number | 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 11:48:50 |
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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
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/
m.mori@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032852
