Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction
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: Measurement of Body Composition, Chart Review.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Breast Cancer. Basic parameters: from 18 years · All.
- 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 →
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Official title
Investigation Into the Utility of Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction
Overview
This study compares measurements of body composition to outcomes of breast reconstruction.
Detailed description
PRIMARY OBJECTIVES:
1\. Determine feasibility of collecting measurements of body composition.
SECONDARY OBJECTIVES:
1. Define the differences in body composition between participants undergoing breast reconstruction who develop complications and those who do not. 2. To determine the implications of different measures of body composition on outcomes of breast reconstruction. 3. Compare utility of body composition measurements versus other anthropometric assessments on assessing risk of complications following breast surgery.
OUTLINE: This is a observational study. Participants are assigned to 1 of 2 cohorts and will be follow-up for up to 2 years.
Interventions
- Procedure Measurement of Body Composition
Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer. - Other Chart Review
Clinical and surgical data will be collected from the participants medical records.
Primary outcome measures
- Proportion of Body Composition Measurement Collection [Time frame: up to 2 years]
Secondary outcome measures (3)
- Postoperative Variability of Body Composition [Time frame: up to 2 years]
- Pre- to Postoperative Changes in Body Composition and Their Association with BMI [Time frame: up to 2 years]
- Association Between Body Composition Parameters and Postoperative Complications Following Breast Reconstruction [Time frame: up to 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
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 · 1 center
- University of California — San Francisco
Identifiers
NCT: NCT07546331 · 25759 · NCI-2026-01299