NCT01433302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

September 8, 2011

Last Update Submit

May 5, 2015

Conditions

Breast CancerGenitourinary CancerMalignant Female Reproductive System NeoplasmMelanomaSarcoma

Keywords

Breast cancerGenitourinary cancerGynecological cancerMalignant Female Reproductive System NeoplasmMelanomaSarcomaInflammatory ResponseInflammatory proteinsTissue FibrosisLymphatico-venous Bypass SurgeryPunch biopsyLab collectionsTh2 immune phenotypeLymphedema

Outcome Measures

Primary Outcomes (1)

  • Th2 Cytokine Levels

    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

Study Arms (1)

Punch Biopsy

Procedure: Punch Biopsy

Interventions

Punch BiopsyPROCEDURE

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.

Punch Biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsUrogenital NeoplasmsMelanomaSarcomaLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms, Connective and Soft TissueLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • David W. Chang, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 13, 2011

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

US(1)