Clinical trial · Observational
Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass
Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis
NCT01433302CI-TRIAL-00017822completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Genitourinary Cancer | Malignant Genitourinary System Neoplasm | ALIAS | 0.90 |
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Punch Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Punch Biopsy
- interventionNames
- Procedure: Punch Biopsy
Primary outcomes (1)
- measure
- Th2 Cytokine Levels
- timeFrame
- 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.