Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01433302|
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : May 6, 2015
|Condition or disease||Intervention/treatment|
|Breast Cancer Genitourinary Cancer Malignant Female Reproductive System Neoplasm Melanoma Sarcoma||Procedure: Punch Biopsy|
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.
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Observational Model:||Case Control|
|Official Title:||Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis|
|Study Start Date :||March 2012|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Procedure: Punch Biopsy
5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.
- Th2 Cytokine Levels [ Time Frame: 6 months ]5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433302
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David W. Chang, MD||M.D. Anderson Cancer Center|