NCT07546331

Brief Summary

This study compares measurements of body composition to outcomes of breast reconstruction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Progress8%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 18, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Breast CarcinomaBreast Cancer

Keywords

Postmastectomy breast reconstruction

Outcome Measures

Primary Outcomes (1)

  • Proportion of Body Composition Measurement Collection

    The proportion of enrolled participants with successfully obtained body composition measurements at both preoperative and postoperative timepoints. A success rate of ≥90% will be considered feasible. The proportion of the participants meets feasibility will be reported.

    up to 2 years

Secondary Outcomes (3)

  • Postoperative Variability of Body Composition

    up to 2 years

  • Pre- to Postoperative Changes in Body Composition and Their Association with BMI

    up to 2 years

  • Association Between Body Composition Parameters and Postoperative Complications Following Breast Reconstruction

    up to 2 years

Study Arms (2)

Cohort A: Implant-based Reconstruction

Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study.

Procedure: Measurement of Body CompositionOther: Chart Review

Cohort B: Autologous Reconstruction

Patients undergo standard of care autologous breast reconstruction and body composition measurement on study.

Procedure: Measurement of Body CompositionOther: Chart Review

Interventions

Measurement of Body CompositionPROCEDURE

Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer.

Cohort A: Implant-based ReconstructionCohort B: Autologous Reconstruction
Chart ReviewOTHER

Clinical and surgical data will be collected from the participants medical records.

Cohort A: Implant-based ReconstructionCohort B: Autologous Reconstruction

Eligibility Criteria

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

Adult participants seen at University California of San Francisco (UCSF) clinics

You may qualify if:

  • Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy.
  • Age ≥ 18 years.
  • Scheduled to undergo mastectomy with immediate breast reconstruction using a permanent implant, tissue expander, or autologous tissue (e.g. Deep Inferior Epigastric Perforator (DIEP) flap, muscle-sparing Transverse Rectus Abdominis Myocutaneous (msTRAM) flap, Profunda Artery Perforator (PAP) flap).
  • Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

  • Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Pregnant or breastfeeding.
  • Patients assigned male at birth.
  • Non-cisgender women.
  • Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator).
  • Patients with prosthetic limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Merisas Piper, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Choi

CONTACT

877-827-3222Michael.Choi@ucsf.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)