UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043005 |
|---|---|
| Receipt number | R000049063 |
| Scientific Title | A study for the impact of immediate breast reconstruction on the prognosis of postoperative breast cancer patients |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/01/15 09:58:59 |
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Basic information
Public title
A study for the impact of immediate breast reconstruction on the prognosis of postoperative breast cancer patients
Acronym
A study for the impact of immediate breast reconstruction on the prognosis of postoperative breast cancer patients
Scientific Title
A study for the impact of immediate breast reconstruction on the prognosis of postoperative breast cancer patients
Scientific Title:Acronym
A study for the impact of immediate breast reconstruction on the prognosis of postoperative breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of oncological safety in immediate breast reconstruction
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relapse-free survival
Key secondary outcomes
overall survival
duration from surgery to initiation of adjuvant chemotherapy
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
Female
Key inclusion criteria
Patients who treated with radical breast cancer surgery at Okayama University Hospital between August 2007 and December 2013.
Key exclusion criteria
Patients who received neoadjuvant chemotherapy, bilateral breast cancer, scheduled delayed reconstruction or prophylactic mastectomy, diagnosed with clinical stage 4, secondary cancer, breast cancer recurrence, and under 20 years old
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Mukai |
Organization
Okayama University Hospital
Division name
Plastic surgey
Zip code
700-8558
Address
Shikata-cho, Kita-ku,Okayama-shi, Okayama-ken 700-8558
TEL
086-235-7214
pkyn874i@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Mukai |
Organization
Okayama University Hospital
Division name
Plastic surgey
Zip code
700-8558
Address
Shikata-cho, Kita-ku,Okayama-shi, Okayama-ken 700-8558
TEL
086-235-7214
Homepage URL
pkyn874i@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Okayama University Hospital, Ethics Committee
Address
Shikata-cho, Kita-ku,Okayama-shi, Okayama-ken 700-8558
Tel
086-235-6938
mae6605@adm.okayama-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | 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
614
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
Preinitiation
Date of protocol fixation
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are planning to extract subjects from the database, analyze them, and publish the results.
Management information
Registered date
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049063
