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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT01433302 |
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Date of registration:
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08/09/2011 |
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Primary sponsor: |
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Public title:
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Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass
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Scientific title:
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Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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22 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01433302 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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David W. Chang, MD |
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Address:
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Telephone:
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713-794-1247 |
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Email:
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Affiliation:
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Name:
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David W. Chang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT MD Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients undergoing lymphatico-venular bypass for stage II or greater lymphedema.
2. History of axillary lymph node dissection.
3. A minimum of one (1) year post-op from original breast or axillary surgery.
4. A minimum of three (3) months post-op from other surgical interventions.
5. A minimum of six (6) months from the last dose of chemotherapy.
6. 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Genitourinary Cancer
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Malignant Female Reproductive System Neoplasm
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Melanoma
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Sarcoma
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Intervention(s)
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Procedure: Punch Biopsy
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Primary Outcome(s)
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Th2 Cytokine Levels
[Time Frame: 6 months]
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Secondary ID(s)
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2011-0455
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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