Post by chaosonline on Nov 4, 2009 10:20:23 GMT -5
Well looka here...the NIH convened a study in 2005 titled "Analysis of Lyme Disease Lesions"
NO results are posted yet! The most recent version (link below) explains criteria changes.
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), May 2009
First Received: August 18, 2005 Last Updated: June 10, 2009 History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00132327
Purpose
This study will analyze cells from erythema migrans lesions, the "bull's eye" rash of Lyme disease. Little is known about what happens in the skin when it is infected with Borrelia burgdorferi, the bacteria that cause Lyme disease. This study will examine and compare laboratory findings in skin biopsies from people with Lyme disease and from healthy normal volunteers to try to better understand the infection.
Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or older may be eligible for this study.
All participants undergo a clinical examination, blood tests, four skin biopsies (removal of a small piece of tissue for laboratory examination), and complete two health questionnaires. The biopsies are taken from the erythema migrans lesion in patients with Lyme disease and from skin on the legs, forearms, buttocks, or side from healthy volunteers. To collect the tissue, the skin at the biopsy site is numbed with injection of a local anesthetic and a sharp instrument is then used to remove a round plug of skin about the size of a pencil eraser. The wound may be closed with one or two sutures, or allowed to heal without sutures. The sutures are removed after a week to 10 days.
Patients with Lyme disease receive treatment for their condition. In addition, at the time the sutures are removed and at 4 weeks, 6 months, and 12 months after their first visit they fill out a questionnaire and have additional blood tests.
Condition
Erythema Migrans Lesions
Erythema Migrans
Study Type: Observational
Official Title: Microarray Analysis of Erythema Migrans Lesions
Resource links provided by NLM:
MedlinePlus related topics: Lyme Disease Rashes
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Estimated Enrollment: 40
Study Start Date: August 2005
Detailed Description:
Little is known of the host and the bacteria response in vivo in patients with Lyme disease. In an attempt to better understand the pathology of erythema migrans (EM), we will use DNA microarrays to characterize gene expression patterns in skin biopsies from individuals with a diagnosis of EM and compared those to the patterns of gene expression seen in biopsies from normal, unaffected individuals. Biopsies from patients may also be evaluated for B. burgdorferi gene expression using microarrays. Patients diagnosed with erythema migrans will have 4 4-mm punch skin biopsies of affected area, and will return for 4 follow up visits in the course of a year. Therapy for Lyme disease will be offered. Healthy volunteers will have a screening visit, a visit for the skin biopsies and a follow up visit. Patients and healthy volunteers will be compensated for their time and inconvenience.
From here:
clinicaltrials.gov/ct2/show/NCT00132327
The Current version of this study with criteria changes:
clinicaltrials.gov/archive/NCT00132327/2009_06_10
karen
NO results are posted yet! The most recent version (link below) explains criteria changes.
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), May 2009
First Received: August 18, 2005 Last Updated: June 10, 2009 History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00132327
Purpose
This study will analyze cells from erythema migrans lesions, the "bull's eye" rash of Lyme disease. Little is known about what happens in the skin when it is infected with Borrelia burgdorferi, the bacteria that cause Lyme disease. This study will examine and compare laboratory findings in skin biopsies from people with Lyme disease and from healthy normal volunteers to try to better understand the infection.
Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or older may be eligible for this study.
All participants undergo a clinical examination, blood tests, four skin biopsies (removal of a small piece of tissue for laboratory examination), and complete two health questionnaires. The biopsies are taken from the erythema migrans lesion in patients with Lyme disease and from skin on the legs, forearms, buttocks, or side from healthy volunteers. To collect the tissue, the skin at the biopsy site is numbed with injection of a local anesthetic and a sharp instrument is then used to remove a round plug of skin about the size of a pencil eraser. The wound may be closed with one or two sutures, or allowed to heal without sutures. The sutures are removed after a week to 10 days.
Patients with Lyme disease receive treatment for their condition. In addition, at the time the sutures are removed and at 4 weeks, 6 months, and 12 months after their first visit they fill out a questionnaire and have additional blood tests.
Condition
Erythema Migrans Lesions
Erythema Migrans
Study Type: Observational
Official Title: Microarray Analysis of Erythema Migrans Lesions
Resource links provided by NLM:
MedlinePlus related topics: Lyme Disease Rashes
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Estimated Enrollment: 40
Study Start Date: August 2005
Detailed Description:
Little is known of the host and the bacteria response in vivo in patients with Lyme disease. In an attempt to better understand the pathology of erythema migrans (EM), we will use DNA microarrays to characterize gene expression patterns in skin biopsies from individuals with a diagnosis of EM and compared those to the patterns of gene expression seen in biopsies from normal, unaffected individuals. Biopsies from patients may also be evaluated for B. burgdorferi gene expression using microarrays. Patients diagnosed with erythema migrans will have 4 4-mm punch skin biopsies of affected area, and will return for 4 follow up visits in the course of a year. Therapy for Lyme disease will be offered. Healthy volunteers will have a screening visit, a visit for the skin biopsies and a follow up visit. Patients and healthy volunteers will be compensated for their time and inconvenience.
From here:
clinicaltrials.gov/ct2/show/NCT00132327
The Current version of this study with criteria changes:
clinicaltrials.gov/archive/NCT00132327/2009_06_10
karen