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Recruiting NCT07597837

Oncoplastic Surgery Outcomes Database

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oncoplastic Breast Surgery.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Understanding Long-Term Outcomes of Oncoplastic Breast Surgery

Overview

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.

Interventions

  • Procedure Oncoplastic Breast 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

Primary outcome measures

  • Cancer Stage [Time frame: From enrollment to up to 1 month after surgery.]
  • Patient Satisfaction [Time frame: From enrollment to 1 year after surgery.]
  • Cancer Recurrence [Time frame: From enrollment to 20 years after surgery]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Tufts Medical Center — Boston
  • Melrose Wakefield Hospital — Melrose

Identifiers

NCT: NCT07597837 · STUDY00006532

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗