Breast Cancer Clinical Trial
Official title:
Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis
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-fibrotic or anti-inflammatory drugs/treatments given with the surgery can improve how well the surgery works.
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 collected from the unaffected arm. A total of 4 samples will be collected
by excisional biopsy (2 samples before the surgery and 2 more samples again 6 months after
the surgery). To collect an excisional biopsy, the area of skin is numbed with anesthetic
and a small cut is made to remove all or part of the affected tissue.
Blood (about 5 teaspoons each time) will also be drawn before the surgery and 1 more blood
sample again 6 months after the surgery. If possible, the blood samples will be collected
during already scheduled blood draws to avoid additional needle sticks.
The tissue and blood samples will be used for testing to evaluate the level of the tissue
inflammation and to check for any build-up of excess tissue.
Length of Study:
After both tissue and blood samples have been collected, your participation in this study
will be over.
This is an investigational study.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
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Observational Model: Case Control, Time Perspective: Prospective
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