- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03105570
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
October 14, 2022 updated by: Houpu Yang, Peking University People's Hospital
To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery.
To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue.
Since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of Areola Sparing Mastectomy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Primary breast cancer originated from areolae is rare.
We hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer.
Areola Sparing Mastectomy (ASM) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.
Study Type
Interventional
Enrollment (Anticipated)
145
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Houpu Yang, MD
- Phone Number: 88324010
- Email: yanghoupu@pkuph.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 10044
- Recruiting
- Peking University People's Hospital
-
Contact:
- Houpu Yang, MD
- Phone Number: 010-88324010
- Email: yanghoupu@pkuph.edu.cn
-
Principal Investigator:
- Shu Wang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically confirmed invasive or in situ breast cancer.
- cTis-2N0-1M0.
- Indicated for total mastectomy and desire immediate breast reconstruction.
Exclusion Criteria:
- cT3-4 or cN2-N3 breast cancer.
- Retraction of nipple or areola.
- Involvement of subcutaneous layer by cancer on ultrasound or MRI.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Areola sparing mastectomy.
Eligible patients undergo areola sparing mastectomy.
|
A small circular incision would be made to separate nipple from breast and an additional incision directly extended from nipple or located at other part of breast such as infra-mammary fold and subaxillary area would be made to remove the total mammary parenchyma.
Routine implant based or flap base reconstruction would be performed subsequentially.
Nipple reconstruction is optional.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of areolar area
Time Frame: Five years after initial surgery
|
The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.
|
Five years after initial surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cosmetic effect of reconstructed breast
Time Frame: 2-4 weeks after surgery; 2 years and 5 years after surgery.
|
The cosmetic results evaluated by a surgeon and a nurse through reviewing photographs.
|
2-4 weeks after surgery; 2 years and 5 years after surgery.
|
Adverse effect of surgery
Time Frame: 4 weeks after surgery.
|
Wound dehiscence, infection, suture exposure and extrusion.
|
4 weeks after surgery.
|
Disease free survival
Time Frame: 5 year after surgery
|
Survival time to any recurrence and any cause death.
|
5 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
April 4, 2017
First Submitted That Met QC Criteria
April 4, 2017
First Posted (Actual)
April 10, 2017
Study Record Updates
Last Update Posted (Actual)
October 17, 2022
Last Update Submitted That Met QC Criteria
October 14, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASM-China
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Neoplasms
-
Emory UniversityEisai Inc.TerminatedBreast Cancer | Breast Neoplasms | Breast Tumors | Neoplasms, Breast | Cancer of the Breast | Tumors, BreastUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
Seagen Inc.CompletedTriple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast NeoplasmsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Providence Health & ServicesBrooklyn ImmunoTherapeutics, LLCActive, not recruitingBreast Neoplasm | Triple Negative Breast Cancer | Breast Neoplasm, MaleUnited States
-
Joseph Baar, MD, PhDCompletedBreast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast CancerUnited States
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCCompletedMale Breast Cancer | Breast - FemaleUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Celgene CorporationTerminatedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
GlaxoSmithKlineCompletedMetastatic Breast Cancer | Neoplasms, BreastJapan
Clinical Trials on Areola Sparing Mastectomy
-
University of MiamiActive, not recruitingBreast Cancer | Ductal CarcinomaUnited States
-
Severance HospitalSamsung Medical Center; Asan Medical Center; Kyungpook National University Chilgok...RecruitingBreast Neoplasms | Benign Breast Disease | Germline BRCA1 Gene Mutation | Germline BRCA2 Gene Mutation | Germline Mutation AbnormalityKorea, Republic of
-
Severance HospitalSamsung Medical Center; Changhua Christian Hospital; European Institute of OncologyCompletedRecurrence | Postoperative Complications | Breast Cancer | Breast Neoplasms | Surgery | Surgery--Complications | BRCA1 Mutation | BRCA2 MutationKorea, Republic of
-
Changhua Christian HospitalMinistry of Science and Technology, Taiwan; Intuitive SurgicalRecruiting
-
Brust-Zentrum AGCompleted
-
Yonsei UniversityRecruitingBreast Cancer Patients in Stage 0-3A in Preoperative EvaluationKorea, Republic of
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Completed
-
Changhua Christian HospitalMinistry of Science and Technology, Taiwan; Intuitive SurgicalUnknownBreast Cancer FemaleTaiwan, Korea, Republic of, Italy
-
Intuitive SurgicalRecruiting
-
Wake Forest University Health SciencesCompletedBreast Cancer | Breast Reconstruction | CosmesisUnited States