Oncoplastic Surgery Outcomes Database

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: Breast Cancer
• Intervention / Treatment: Procedure: Oncoplastic Breast Surgery

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

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center
      • Principal Investigator: Sarah Persing, MD
      • Contact: Sarah Persing, MD; Phone Number: 617-636-5600; Email: sarah.persing1@tuftsmedicine.org
    • Melrose, Massachusetts, United States, 02176
      • Active, not recruiting
      • Melrose Wakefield Hospital

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	From enrollment to 1 year after surgery.
Cancer Recurrence	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	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	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

• Sponsor: Tufts Medical Center

Study record dates

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: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• 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