NCT07597837

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
226mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Feb 2026Jan 2045

Study Start

First participant enrolled

February 26, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
18.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2045

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2045

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

18.9 years

First QC Date

April 30, 2026

Last Update Submit

May 13, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Positive Margin Rate

    From enrollment to 1 year after initial surgery

  • Surgical Complication Rate

    From date of surgery up to 5 years after surgery

Interventions

Oncoplastic Breast SurgeryPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Biological females \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Melrose Wakefield Hospital

Melrose, Massachusetts, 02176, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 19, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

January 1, 2045

Study Completion (Estimated)

January 1, 2045

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)