UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008136 |
|---|---|
| Receipt number | R000009580 |
| Scientific Title | Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrences |
| Date of disclosure of the study information | 2012/06/30 |
| Last modified on | 2017/01/18 13:39:29 |
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Basic information
Public title
Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrences
Acronym
Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrences
Scientific Title
Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrences
Scientific Title:Acronym
Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrences
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether breast cancer subtype is associated with distant recurrences after IBTR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of breast cancer subtype with distant recurrences after IBTR.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) patients who underwent breast-conserving surgery and axillary surgery (sentinel lymph node biopsy only was allowed if these nodes had no metastases); (2) patients who confirmed IBTR histologically; (3) patients who underwent definitive surgery for IBTR until 2008.
Key exclusion criteria
(1) synchronous (defined as occurring within 3 months) metastases;(2) bilateral breast cancer patients; (3) non-invasive tumor at IBTR specimen; (4) prior malignancy other than breast cancer; (5) patients with tumors located in the skin or muscle only without associated parenchymal disease; (6) patients who received neoadjuvant therapy at the initial treatment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ishitobi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-3-3, Nakamichi, higasinari-ku, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ishitobi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society
Institute
Department
Personal name
Funding Source
Organization
The Japanese Breast Cancer Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 01 | Month | 18 | Day |
Other
Other related information
Clinico-pathological factors of primary breast cancer and ipsilateral breast tumor recurrences
Management information
Registered date
| 2012 | Year | 06 | Month | 11 | Day |
Last modified on
| 2017 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009580
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
