Breast CancerNCT07597837
Oncoplastic Surgery Outcomes Database
An observational study of Breast Cancer, run by Tufts Medical Center at 2 sites in United States.
Trial summary
This is a retrospective and prospective chart review of surgical outcomes and collecting patient satisfaction outcomes using validated surveys for oncoplastic breast surgery and Goldilocks mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Oncoplastic Breast Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2026to Jan 2045
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients of Tufts Medicine hospitals requiring oncologic breast surgery with and without reconstruction.
Who may be able to join
- Biological females >= 18 years old requiring oncologic breast surgery with and without reconstruction at Tufts Medicine.
Who cannot join
- Biological females < 18 years old
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Sarah Persing, MD, 617-636-5600, sarah.persing1@tuftsmedicine.org
Sarah Persing, MD
- Active, not recruiting
Melrose Wakefield Hospital
Melrose, Massachusetts, 02176
About this study
Official title: Understanding Long-Term Outcomes of Oncoplastic Breast Surgery
This is a retrospective and prospective chart review of surgical outcomes and collecting patient satisfaction outcomes using validated surveys for oncoplastic breast surgery and Goldilocks mastectomy.
Read the detailed description
This is a retrospective and prospective chart review from 2015-2045 of oncoplastic breast surgery and mastectomy patients at Tufts Medicine.
- Conditions
- Breast Cancer
- Being tested
- Oncoplastic Breast Surgery
- 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 Breast SurgeryProcedure or surgery
Breast conservation surgery incorporating an oncologic partial mastectomy with ipsilateral defect repair using volume displacement or volume replacement techniques with contralateral symmetry surgery as appropriate
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Stage
The TNM system of cancer classification determines the stage of cancer based on type of cancer, size of cancer, lymph node status, presence of metastasis
Measured: From enrollment to up to 1 month after surgery.
Patient Satisfaction
Measured using validated surveys pre-operative and post-operative (2 week, 6 month, 1 year).
Measured: From enrollment to 1 year after surgery.
Cancer Recurrence
Recurrence of cancer following surgery and adjuvant therapy
Measured: From enrollment to 20 years after surgery
Secondary outcomes (2)
Positive Margin Rate
The investigators will measure rates of positive margins after cancer resection that requires additional resection.
Measured: From enrollment to 1 year after initial surgery
Surgical Complication Rate
Complications from surgery (infection, wound dehiscence, seroma, hematoma, etc.) will be measured and aggregated into a overall rate of major complications (requires intervention) and minor complications as percentages.
Measured: From date of surgery up to 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start26 Feb 2026
- Primary completionJan 2045 (estimated)
- Study completionJan 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597837
- Sponsor's protocol ID
- STUDY00006532
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Long-Term Outcomes of Oncoplastic Breast Surgery
- ClinicalTrials.gov ID
- NCT07597837
- Acronym / sponsor ID
- STUDY00006532
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Jan 2045 (estimated)
- Study completion
- Jan 2045 (estimated)
- First posted
- 19 May 2026 (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.
This is a retrospective and prospective chart review of surgical outcomes and collecting patient satisfaction outcomes using validated surveys for oncoplastic breast surgery and Goldilocks mastectomy.
Detailed description
This is a retrospective and prospective chart review from 2015-2045 of oncoplastic breast surgery and mastectomy patients at Tufts Medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Tufts Medicine hospitals requiring oncologic breast surgery with and without reconstruction.
Key inclusion criteria (1 listed)
- Biological females >= 18 years old requiring oncologic breast surgery with and without reconstruction at Tufts Medicine.
Key exclusion criteria (1 listed)
- Biological females < 18 years old
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 Breast SurgeryBreast conservation surgery incorporating an oncologic partial mastectomy with ipsilateral defect repair using volume displacement or volume replacement techniques with contralateral symmetry surgery as appropriate | Procedure or surgery | – |
Primary outcome
Cancer Stage
Time frame: From enrollment to up to 1 month after surgery.
The TNM system of cancer classification determines the stage of cancer based on type of cancer, size of cancer, lymph node status, presence of metastasis
Patient Satisfaction
Time frame: From enrollment to 1 year after surgery.
Measured using validated surveys pre-operative and post-operative (2 week, 6 month, 1 year).
Cancer Recurrence
Time frame: From enrollment to 20 years after surgery
Recurrence of cancer following surgery and adjuvant therapy
2 secondary outcomes
Positive Margin Rate
Time frame: From enrollment to 1 year after initial surgery
Surgical Complication Rate
Time frame: From date of surgery up to 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Tufts Medical Center at 2 sites in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer Stage (time frame: From enrollment to up to 1 month after surgery.). The study lists 3 primary outcomes in all. 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 27 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.