Breast CarcinomaNCT07546331
Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction
An observational study of Breast Carcinoma and Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study compares measurements of body composition to outcomes of breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Breast Cancer
- What is being tested?
- Measurement of Body Composition and Chart Review
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants seen at University California of San Francisco (UCSF) clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California
San Francisco, California, 94143
Michael Choi, 877-827-3222, Michael.Choi@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Investigation Into the Utility of Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction
This study compares measurements of body composition to outcomes of breast reconstruction.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine feasibility of collecting measurements of body composition.
SECONDARY OBJECTIVES:
- Define the differences in body composition between participants undergoing breast reconstruction who develop complications and those who do not.
- To determine the implications of different measures of body composition on outcomes of breast reconstruction.
- 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.
- Conditions
- Breast Carcinoma, Breast Cancer
- Being tested
- Measurement of Body Composition, Chart Review
- Keywords
- Postmastectomy breast reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Body CompositionProcedure or surgery
Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer.
Chart ReviewOther
Clinical and surgical data will be collected from the participants medical records.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Implant-based Reconstruction | Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study. Receives: Procedure: Measurement of Body Composition; Other: Chart Review | |
| Cohort B: Autologous Reconstruction | Patients undergo standard of care autologous breast reconstruction and body composition measurement on study. Receives: Procedure: Measurement of Body Composition; Other: Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years
Secondary outcomes (3)
Postoperative Variability of Body Composition
To investigate how body fat measurements change after surgery and how consistent these measurements are when repeated.
Measured: up to 2 years
Pre- to Postoperative Changes in Body Composition and Their Association with BMI
Associations between body fat parameters and changes in BMI will be evaluated using correlative analyses.
Measured: up to 2 years
Association Between Body Composition Parameters and Postoperative Complications Following Breast Reconstruction
The association between body composition parameters and postoperative complications following breast reconstruction will be examined. Complications of interest include infection, seroma, hematoma, delayed wound healing, and tissue necrosis.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start18 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merisas Piper, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546331
- Sponsor's protocol ID
- 25759
- Other IDs
- NCI-2026-01299
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Utility of Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07546331
- Acronym / sponsor ID
- 25759
- Conditions
- Breast Carcinoma, Breast Cancer
- Keywords
- Postmastectomy breast reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares measurements of body composition to outcomes of breast reconstruction.
Detailed description
PRIMARY OBJECTIVES:
- Determine feasibility of collecting measurements of body composition.
SECONDARY OBJECTIVES:
- Define the differences in body composition between participants undergoing breast reconstruction who develop complications and those who do not.
- To determine the implications of different measures of body composition on outcomes of breast reconstruction.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Implant-based Reconstruction | – | Procedure: Measurement of Body Composition, Other: Chart ReviewPatients undergo standard of care implant-based breast reconstruction and body composition measurement on study. |
| Cohort B: Autologous Reconstruction | – | Procedure: Measurement of Body Composition, Other: Chart ReviewPatients undergo standard of care autologous breast reconstruction and body composition measurement on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants seen at University California of San Francisco (UCSF) clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Body CompositionBody composition measurements collected pre and post operatively using a bioelectrical impedance analyzer. | Procedure or surgery | Cohort A: Implant-based Reconstruction, Cohort B: Autologous Reconstruction |
| Chart ReviewClinical and surgical data will be collected from the participants medical records. | Other | Cohort A: Implant-based Reconstruction, Cohort B: Autologous Reconstruction |
Primary outcome
Proportion of Body Composition Measurement Collection
Time frame: up to 2 years
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merisas Piper, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Choi (877-827-3222, Michael.Choi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Body Composition Measurement Collection (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.