Status:
COMPLETED
Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Breast Cancer
Genitourinary Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this clinical research study is to measure the amount of inflammatory proteins inside the body before and after lymphatico-venular bypass surgery. This will help doctors learn if anti-fibr...
Detailed Description
If you choose to take part in this study, you will have 1 small piece of tissue (about the size of a pencil eraser) collected from the arm with the lymphedema and another small piece of tissue will be...
Eligibility Criteria
Inclusion
- Patients undergoing lymphatico-venular bypass for lymphedema.
- History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.
- A minimum of three (3) months post-op from any surgical interventions.
- A minimum of six (6) months from the last dose of chemotherapy.
- Patients with unilateral lymphedema.
Exclusion
- Active systemic infection or allergic reaction.
- Active parasitic infection.
- History of primary (congenital) lymphedema.
- Metastatic cancer.
- History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.
- History of other fibroproliferative disorders including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.
- Current treatment with steroids.
- Concurrent secondary systemic cancer exclusive of cutaneous malignancies.
- Treatment with myelosuppressive or stimulatory drugs within six (6) months of enrollment.
- History of bone marrow transplantation.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01433302
Start Date
March 1 2012
End Date
March 1 2014
Last Update
May 6 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030