Trial record 2 of 105 for:    Melanoma (women OR woman OR female)

Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01433302
First received: September 8, 2011
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Genitourinary Cancer
Malignant Female Reproductive System Neoplasm
Melanoma
Sarcoma
Procedure: Punch Biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Th2 Cytokine Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: March 2012
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433302

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David W. Chang, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01433302     History of Changes
Other Study ID Numbers: 2011-0455, BC103691
Study First Received: September 8, 2011
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Malignant Female Reproductive System Neoplasm
Melanoma
Breast cancer
Genitourinary cancer
Gynecological cancer
Sarcoma
Inflammatory Response
Inflammatory proteins
Tissue Fibrosis
Lymphatico-venous Bypass Surgery
Punch biopsy
Lab collections
Th2 immune phenotype
Lymphedema

Additional relevant MeSH terms:
Melanoma
Genital Neoplasms, Female
Nevi and Melanomas
Neoplasms
Sarcoma
Fibrosis
Breast Neoplasms
Urogenital Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014