Oncoplastic Surgery Outcomes Database

May 22, 2026 updated by: Tufts Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective and prospective chart review from 2015-2045 of oncoplastic breast surgery and mastectomy patients at Tufts Medicine.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Sarah Persing, MD
        • Contact:
      • Melrose, Massachusetts, United States, 02176
        • Active, not recruiting
        • Melrose Wakefield Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of Tufts Medicine hospitals requiring oncologic breast surgery with and without reconstruction.

Description

Inclusion Criteria:

  • Biological females >= 18 years old requiring oncologic breast surgery with and without reconstruction at Tufts Medicine.

Exclusion Criteria:

  • Biological females < 18 years old

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to up to 1 month after surgery.
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).
From enrollment to 1 year after surgery.
Cancer Recurrence
Time Frame: From enrollment to 20 years after surgery
Recurrence of cancer following surgery and adjuvant therapy
From enrollment to 20 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Margin Rate
Time Frame: From enrollment to 1 year after initial surgery
The investigators will measure rates of positive margins after cancer resection that requires additional resection.
From enrollment to 1 year after initial surgery
Surgical Complication Rate
Time Frame: From date of surgery up to 5 years after surgery
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.
From date of surgery up to 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

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)

February 26, 2026

Primary Completion (Estimated)

January 1, 2045

Study Completion (Estimated)

January 1, 2045

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006532

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.

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