UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054943 |
|---|---|
| Receipt number | R000062176 |
| Scientific Title | Study of Breast Conserving Surgery Using Pectoralis Major Muscle Flap |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2024/07/12 00:51:36 |
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Basic information
Public title
Study of Breast Conserving Surgery Using Pectoralis Major Muscle Flap
Acronym
Study of Breast Conserving Surgery Using Pectoralis Major Muscle Flap
Scientific Title
Study of Breast Conserving Surgery Using Pectoralis Major Muscle Flap
Scientific Title:Acronym
Exploratory Study on Partial Breast Reconstruction Using Pectoralis Major Muscle Flap in Breast Cancer Surgery
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety (with a focus on surgical complications and oncological safety including local recurrence rates) and effectiveness (in terms of cosmetic outcomes and improvement in quality of life) of reconstruction using a pedicled pectoralis major muscle flap following partial mastectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation (adverse event incidence rate)
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pectoralis major muscle flap for partial breast reconstruction
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients with primary breast cancer undergoing partial mastectomy at Nakagami Hospital from the approval of the ethics review to March 2026.
2. Patients for whom significant postoperative breast deformity is expected with partial mastectomy alone.
Key exclusion criteria
1. Patients suspected of having pectoralis major muscle invasion based on preoperative MRI or CT scans.
2. Patients who desire full breast reconstruction with silicone implants in the future.
3. Patients with Poland syndrome or pectoralis major muscle defects due to trauma.
4. Patients with uncontrolled underlying diseases.
5. Patients deemed unsuitable by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Katsuragi |
Organization
Nakagami Hospital
Division name
Breast Surgery
Zip code
904-2195
Address
610 Noborikawa, Okinawa City, Okinawa Prefecture, Japan
TEL
0989391300
katsuragi@nakagami.or.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Katsuragi |
Organization
Nakagami Hospital
Division name
Brest surgery
Zip code
904-2195
Address
610 Noborikawa, Okinawa City, Okinawa Prefecture, Japan
TEL
0989391300
Homepage URL
katsuragi@nakagami.or.jp
Sponsor or person
Institute
Ryohei Katsuragi, Department of Breast surgery, Nakagami Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
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
Nakagami Hospital
Address
610 Noborikawa, Okinawa City, Okinawa Prefecture, Japan
Tel
0989391300
katsuragi@nakagami.or.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
中頭病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062176
