Oncoplastic Breast SurgeryNCT05179304
Aesthetic Outcomes of Oncoplastic Breast Surgery for Breast Cancer in the Upper Inner Quadrant
A study testing Oncoplastic technique with a droplet-shaped glandular flap in people with Oncoplastic Breast Surgery and Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Oncoplastic Breast Surgery, Breast Cancer, Aesthetic Outcomes
- What is being tested?
- Oncoplastic technique with a droplet-shaped glandular flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent.
- Female aged between 18 and 70 years.
- Pathologically diagnosed operable breast cancer.
- WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant.
- The important organ functions meet the following criteria:
Show all 12Show fewer
- WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;
- Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
- Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min;
- Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
- LVEF basement >= 50%.
- Adjust to the criteria of breast conserving surgery.
Who cannot join
- Multifocal or multicentric disease.
- Tumor localized in the central quadrant or the distance to the nipple < 2 cm；
- Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
- The ratio of tumor to breast > 20%;
- The diameter of tumor is up to 4 cm;
- Women in the early or intermediate stage of pregnancy;
- Prior history of breast radiation;
- Any severe comorbidities, inability to give informed consent or unavailability for follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shicheng Su
Guangzhou, Guangdong, 510120
Shicheng Su, M.D., Ph.D., +86 13631304227, sushch@mail.sysu.edu.cn
About this study
Official title: Aesthetic Outcomes of Oncoplastic Breast Surgery With a Droplet-Shaped Glandular Flap for Breast Cancer in the Upper Inner Quadrant
Oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. The upper inner quadrant is one of the most difficult and challenging tumor locations for surgeons to perform oncoplastic breast surgery. There is a pressing need to develop a simple and effective oncoplastic surgical technique to cope with the unfavorable anatomy and location of tumors in the UIQ. Here, we present a new oncoplastic volume displacement technique for UIQ using the DSG flap. This trial was design to estimate the aesthetic outcomes of an oncoplastic technique using a droplet-shaped glandular flap for breast cancer in the upper inner quadrant.
- Being tested
- Oncoplastic technique with a droplet-shaped glandular flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncoplastic technique with a droplet-shaped glandular flapProcedure or surgery
A droplet-shaped glandular flap (DSG) is in a shape of a water drop, with the pedicle at the top of the defect and the base underlying nipple-areolar complex (NAC). It runs from the outer upper quadrant to the center along a line parallel to the radial line. We harvest a DSG flap by dissociating the supplement mammary gland from the lateral of the defect after resection, developing deep to the pectoralis fascia, from the cusp at the defect and the round pore underlying nipple-areolar complex (NAC). The DSG flap was rotated inwards around the cusp, reaching the top of the defect. This tailored redistribution allowed the defects to be "plugged" with the lateral glandular flaps.
| Study group | Role | What they receive |
|---|---|---|
| Oncoplastic technique with a droplet-shaped glandular flap | Experimental | Not described Receives: Procedure: Oncoplastic technique with a droplet-shaped glandular flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
aesthetic outcomes
ABNSW system. The total score was 15 points, outcomes were good when it was 11-14, fair when it was 6-10, and poor when it was 0-5.
Measured: half a year to one year
Secondary outcomes (3)
Patients' quality of life
EORTC QLQ-C30 questionnaire
Measured: half a year to one year
Local recurrence
Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall.
Measured: half a year to one year
Patients complications after surgery
The occurence of scarring, radiation fibrosis, seroma, fat necrosis and infection
Measured: half a year to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start18 Jan 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncoplastic Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shicheng Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179304
- Sponsor's protocol ID
- 2021-KY-124-001
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Outcomes of Oncoplastic Breast Surgery With a Droplet-Shaped Glandular Flap for Breast Cancer in the Upper Inner Quadrant
- ClinicalTrials.gov ID
- NCT05179304
- Acronym / sponsor ID
- 2021-KY-124-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. The upper inner quadrant is one of the most difficult and challenging tumor locations for surgeons to perform oncoplastic breast surgery. There is a pressing need to develop a simple and effective oncoplastic surgical technique to cope with the unfavorable anatomy and location of tumors in the UIQ. Here, we present a new oncoplastic volume displacement technique for UIQ using the DSG flap. This trial was design to estimate the aesthetic outcomes of an oncoplastic technique using a droplet-shaped glandular flap for breast cancer in the upper inner quadrant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncoplastic technique with a droplet-shaped glandular flap | Experimental | Procedure: Oncoplastic technique with a droplet-shaped glandular flap |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed the informed consent.
- Female aged between 18 and 70 years.
- Pathologically diagnosed operable breast cancer.
- WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant.
Key exclusion criteria (8 listed)
- Multifocal or multicentric disease.
- Tumor localized in the central quadrant or the distance to the nipple < 2 cm；
- Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
- The ratio of tumor to breast > 20%;
- The diameter of tumor is up to 4 cm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncoplastic technique with a droplet-shaped glandular flapA droplet-shaped glandular flap (DSG) is in a shape of a water drop, with the pedicle at the top of the defect and the base underlying nipple-areolar complex (NAC). It runs from the outer upper quadrant to the center along a line parallel to the radial line. We harvest a DSG flap by dissociating the supplement mammary gland from the lateral of the defect after resection, developing deep to the pectoralis fascia, from the cusp at the defect and the round pore underlying nipple-areolar complex (NAC). The DSG flap was rotated inwards around the cusp, reaching the top of the defect. This tailored redistribution allowed the defects to be "plugged" with the lateral glandular flaps. | Procedure or surgery | Oncoplastic technique with a droplet-shaped glandular flap |
Primary outcome
aesthetic outcomes
Time frame: half a year to one year
ABNSW system. The total score was 15 points, outcomes were good when it was 11-14, fair when it was 6-10, and poor when it was 0-5.
3 secondary outcomes
Patients' quality of life
Time frame: half a year to one year
Local recurrence
Time frame: half a year to one year
Patients complications after surgery
Time frame: half a year to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncoplastic technique with a droplet-shaped glandular flap in people with Oncoplastic Breast Surgery and Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shicheng Su, M.D.,Ph.d. (+8613631304227, sushch@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aesthetic outcomes (time frame: half a year to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.