UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037067 |
|---|---|
| Receipt number | R000042239 |
| Scientific Title | Identification of high-risk groups for ipsilateral breast tumor recurrence among candidates for omission of breast surgery |
| Date of disclosure of the study information | 2019/06/14 |
| Last modified on | 2021/12/15 15:08:40 |
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Basic information
Public title
TOPS
Acronym
TOPS
Scientific Title
Identification of high-risk groups for ipsilateral breast tumor recurrence among candidates for omission of breast surgery
Scientific Title:Acronym
Identification of high-risk groups for ipsilateral breast tumor recurrence
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the risk factors of ipsilateral breast tumor recurrence (IBTR) among breast cancer patients who received neoadjuvant chemotherapy (NAC) and breast-conserving treatment (BCT) and obtained pathological complete response (pCR).
Basic objectives2
Others
Basic objectives -Others
risk evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IBTR rate
Key secondary outcomes
Identification of high- or low-risk groups of IBTR
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Triple-negative or HER2-positive breast cancer patients who received NAC and BCT and obtained pCR
Key exclusion criteria
Stage 4 breast cancer patients
Patients who had tumorectomy before NAC
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ishitobi |
Organization
Osaka International Cancer Institute
Division name
Departments of Breast and Endocrine Surgery
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
0669451181
isitobi-ma@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ishitobi |
Organization
Osaka International Cancer Institute
Division name
Departments of Breast and Endocrine Surgery
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
0669451181
Homepage URL
isitobi-ma@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
Tel
0669451181
rinri01@opho.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 | 06 | Month | 14 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 15 | Day |
Other
Other related information
multicenter retrospective cohort study
Management information
Registered date
| 2019 | Year | 06 | Month | 14 | Day |
Last modified on
| 2021 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042239
