UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054462 |
|---|---|
| Receipt number | R000062208 |
| Scientific Title | Evaluation of the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy |
| Date of disclosure of the study information | 2024/05/22 |
| Last modified on | 2024/05/22 22:12:48 |
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Basic information
Public title
Prospective multi-institutional study to evaluate the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy(FUSION-03)
Acronym
Evaluation of the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy
Scientific Title
Evaluation of the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy
Scientific Title:Acronym
Evaluation of the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy
Region
| Japan |
Condition
Condition
Breast cancer patients with posotive lymph node metastasis who need neoadjuvant chemotherapy
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Detection rate of the marker in intra-tumoal tumror by virtual sonography aftr neoadjuvant chemotherapy
Key secondary outcomes
1) Number of lymph nodes in TAS & Ax specimen
2) False positive rate of positive lymph nods in TAS & Ax specimen
3) Radiological detection rate of tje intra-tumoal tumor by US-US fusion, US-CT fusion image
4) Time till detection of the intra-tumoal tumor by virtual somnography
5) Adverse events
6)Radiological change of the marker located in the positive lymph node
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
1)Primary breast cancer with pathologically node-positive
2)cT0-T4, cN1-3, M0(cStage IIA-IIIC)
3)patient who need NAC
4)more than 20yo, male and female
5)PS 0-2
6)available for insertion of the intra-tumoral marker
7)agree to participate in this trial
Key exclusion criteria
1)imposible to insert intra-tumoal marker
2)not agreed to perform TAS&Ax
3)impossible to perform NAC becauseof medical problem, HBV/HVC-positive case in acceptable with anappropriate treatment
4)pregnant
5)mental disorder
6) decision not appropriate to join the trial by PI
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Futamura |
Organization
Gifu University Hospital
Division name
Department of breast surgery
Zip code
501-1194
Address
Yanagido Gifu
TEL
0582306000
futamura.manabu.m3@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Futamura |
Organization
Department of breast surgery Gifu University Graduate school of Medicine
Division name
Department of breast surgery Gifu University Graduate school of Medicine
Zip code
501-1194
Address
1-1 Yanagido Gifu
TEL
0582306000
Homepage URL
futamura.manabu.m3@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Manabu Futamura
Funding Source
Organization
Gifu Univsetity
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Ethics Review Committeee
Address
1-1 Yanagido Gifu
Tel
0582306000
rinri@t.gifu-u.ac.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
岐阜大学医学部附属病院（岐阜県） 愛知医科大学病院（愛知県） 東京女子医科大学病院乳腺外科 （東京都） 千葉大学医学部附属病院（千葉県）
大垣市民病院（岐阜県）がん研有明病院（東京都） 岐北厚生病院（岐阜県） 昭和大学江東豊洲病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062208
