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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03182 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0528 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.
PRIMARY OBJECTIVE:
I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction.
SECONDARY OBJECTIVES:
I. Determine the overall complications of prophylactic vascularized lymph node transfers.
II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer.
OUTLINE:
Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (vascularized lymph node transfer) | Experimental | Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mammoplasty | Procedure | Undergo standard of care breast reconstructive surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of lymphedema development | Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated. | At 12 months after surgery |
| Time to lymphedema development | Will be estimated by the Kaplan-Meier method. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of lymphedema development | The incidence of lymphedema between patients who undergo vascularized lymph node transfer (VLNT) and historical cohorts who do not will be compared. The inverse probability of treatment weighting using the propensity scores will be applied to estimate the effect of VLNT. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward I Chang | 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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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2022 | Oct 7, 2024 |
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| Vascularized Lymph Node Transfer | Procedure | Undergo vascularized lymph node transfer |
|
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| Complications of prophylactic VLNT |
Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated. |
| Within 30 days after surgery |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016462 | Mammaplasty |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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