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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01801878 |
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Date of registration:
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27/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
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Scientific title:
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Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts |
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Date of first enrolment:
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December 1, 2020 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT01801878 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Chanyeong Heo, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Bundang Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female aged between 40 and 60
- Subjects who diagnosed breast ductal carcinoma in situ of surgical staging T1aN0,
negative resection margin of below 2mm in histopathologic examination
- Subjects who have a relapse-free interval of more than one year after
breast-conserving surgery for breast cancer and radiation therapy
- Subjects who understand the study contents and sign the informed consent
Exclusion Criteria:
- Subjects who have radiodermatitis
- Subjects who planned breast reconstruction with autogenous tissue (ex.Transverse
Rectus Abdominis Muscle flap)
- Subjects who have a history of smoking within 3months recently
- Subjects who participated in other clinical trial within 30 days recently
- Pregnant or lactating subjects
- Subjects who have a active infectious disease
- Subjects who are not eligible for this study at the discretion of the investigator
Age minimum:
40 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Skin Abnormalities
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Intervention(s)
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Biological: Adipose SVF cell
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Biological: Normal saline
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Primary Outcome(s)
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The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
[Time Frame: change in the breast skin thickness from baseline at 12 week]
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Secondary ID(s)
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06-2012-193
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B-1206-158-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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