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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-05588 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2023-0320 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| Artidis | INDUSTRY |
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This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.
PRIMARY OBJECTIVE:
I. Characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction.
OUTLINE: This is an observational study.
Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Nanomechanical properties of the skin and adjacent soft tissue | The nanomechanical properties will be presented as a histogram that describes the characteristics of the sample. For each skin sample, summary statistics including mean (median), standard deviation, skewness, and range, mode, etc. will be used to describe the nanomechanical properties. Wilcoxon rank sum test or Fisher's exact test will be used to study the association between the summarized nanomechanical properties and clinical factors or outcomes. Pearson correlation coefficients will be used to assess the strength of association between any two continuous variables. Logistic regression will be conducted to examine the effect of nanomechanical properties on the risk of implant loss or any complication after adjusting other clinical factors. | At time of surgery |
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Inclusion Criteria:
* Age 18 and older
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Women with history of mastectomy with tissue expander placement recruited from MD Anderson.
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin D Smith, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | 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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| D017437 |
| Skin and Connective Tissue Diseases |