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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-01299 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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This study compares measurements of body composition to outcomes of breast reconstruction.
PRIMARY OBJECTIVES:
1. Determine feasibility of collecting measurements of body composition.
SECONDARY OBJECTIVES:
OUTLINE: This is a observational study. Participants are assigned to 1 of 2 cohorts and will be follow-up for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Implant-based Reconstruction | Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study. |
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| Cohort B: Autologous Reconstruction | Patients undergo standard of care autologous breast reconstruction and body composition measurement on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of Body Composition | Procedure | Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Variability of Body Composition | To investigate how body fat measurements change after surgery and how consistent these measurements are when repeated. | up to 2 years |
| Pre- to Postoperative Changes in Body Composition and Their Association with BMI |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants seen at University California of San Francisco (UCSF) clinics
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Choi | Contact | 877-827-3222 | Michael.Choi@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Merisas Piper, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Recruiting | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Chart Review | Other | Clinical and surgical data will be collected from the participants medical records. |
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Associations between body fat parameters and changes in BMI will be evaluated using correlative analyses. |
| 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. | up to 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |