Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT01433302
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2011-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-fibrotic or anti-inflammatory drugs/treatments given with the surgery can improve how well the surgery works.
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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BC103691 | OTHER | Department of Defense | View |