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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-05054 | Other Identifier | NCI-CTRP Clinical Registry |
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To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Primary Objectives
- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative Evaluations | Experimental | Participants who agree to take part in this study, clinic visit timing will be exactly the same time as would ordinarily be scheduled: before surgery, then 6, 12, 18, and 24 months after surgery. Each study visit should take about 2-3 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Lymphatic Reconstruction (ILR)/ | Procedure | Given by Procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from lymphedema (FFL) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Hull, MHA, BA, BSN, RN, CCRP | Contact | 713-794-1247 | sehull@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Mark Schaverien, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jun 6, 2024 | May 21, 2025 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Prophylactic Lymphovenous Bypass (pLVB) |
| Procedure |
Given by Procedure |
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