Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass

May 5, 2015 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

UT MD Anderson Cancer Center patients, 18 years of age or older, undergoing lymphatico-venular bypass for stage II or greater lymphedema.

Description

Inclusion Criteria:

  1. Patients undergoing lymphatico-venular bypass for lymphedema.
  2. History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.
  3. A minimum of three (3) months post-op from any surgical interventions.
  4. A minimum of six (6) months from the last dose of chemotherapy.
  5. Patients with unilateral lymphedema.

Exclusion Criteria:

  1. Active systemic infection or allergic reaction.
  2. Active parasitic infection.
  3. History of primary (congenital) lymphedema.
  4. Metastatic cancer.
  5. History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.
  6. History of other fibroproliferative disorders including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.
  7. Current treatment with steroids.
  8. Concurrent secondary systemic cancer exclusive of cutaneous malignancies.
  9. Treatment with myelosuppressive or stimulatory drugs within six (6) months of enrollment.
  10. History of bone marrow transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Punch Biopsy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: David W. Chang, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (Estimate)

September 13, 2011

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0455
  • BC103691 (Other Identifier: Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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