UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012035 |
|---|---|
| Receipt number | R000014067 |
| Scientific Title | Feasibility Study to Assess Diagnostic Accuracy of Pathological Complete Response with Core Needle Biopsy |
| Date of disclosure of the study information | 2013/10/15 |
| Last modified on | 2018/04/23 15:29:25 |
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Basic information
Public title
Feasibility Study to Assess Diagnostic Accuracy of Pathological Complete Response with Core Needle Biopsy
Acronym
CNB for Breast Cancer Acquired cCR with NAC
Scientific Title
Feasibility Study to Assess Diagnostic Accuracy of Pathological Complete Response with Core Needle Biopsy
Scientific Title:Acronym
CNB for Breast Cancer Acquired cCR with NAC
Region
| Japan |
Condition
Condition
Invasive Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess feasibility of diagnostic accuracy of pathological complete response (pCR) with core needle biopsy(CNB) for breast cancer patient who acquired clinical complete response (cCR) with neoadjuvant chemothrapy. If pCR is diagnosed with CNB correctly, we have opportunity to omit surgical procedure for resection.
Basic objectives2
Others
Basic objectives -Others
Feasibility study to assess diagnostic accuracy of pathological complete response with core needle biopsy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of pCR with CNB
Key secondary outcomes
Accuracy of pCR with imaging study.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Core needle biopsy is performed just before resection of the primary lesion under general anesthegia for the resection procedure.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1) Woman age of 20 to 75 years old at registration.
2) Invasive breast cancer proven by core biopsy.
3) Negative for estrogen receptor immunohistochemically.
4) No prior therapy including radiation, endocrine therapy or immunotherapy except for neoadjuvant chemotherapy for existing breast cancer.
5) Expected complete response for invasive cancer by neoadjuvant chemotherapy with imaging study.
6) Informed consent must be obtained before patient registration.
Key exclusion criteria
1) Male gender
2) Judged to be inadequate by the doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Narui |
Organization
Yokohama City University Medical Center
Division name
Department of Breast and Thyroid Surgery
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
nr1@gc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Narui |
Organization
Yokohama City University Medical Center
Division name
Department of Breast and Thyroid Surgery
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
nr1@gc5.so-net.ne.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
横浜市立大学附属市民総合医療センター（神奈川県）
東海大学付属病院（神奈川県）
聖マリアンナ医科大学病院（神奈川県）
聖マリアンナ医科大学ブレスト＆イメージング（神奈川県）
北里大学病院（神奈川県）
神奈川県立がんセンター（神奈川県）
大船中央病院（神奈川県）
横浜労災病院（神奈川県）
湘南記念病院（神奈川県）
横浜市立みなと赤十字病院（神奈川県）
横浜旭中央総合病院（神奈川県）
東海大学付属八王子病院（神奈川県）
横浜市立大学附属病院（神奈川県）
弘前市立病院（青森県）
東京医科大学八王子医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 15 | 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
| 2013 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 15 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014067
| 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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