Trial record 13 of 203 for:
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
This study has been completed.
Information provided by (Responsible Party):
First received: June 5, 2013
Last updated: April 16, 2014
Last verified: April 2014
To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
- Summarized the number and percentage of subjects with elevated LOXL2 levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- 5 mL blood draw for LOXL2 testing
- 2 Punch Skin Biopsies (one near the scleroderma lesion, the other from normal skin)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult subjects with documented diagnoses of scleroderma will be enrolled into one of two cohorts, depending upon the subject's diagnosis
- Over 18 years of age
- Documented diagnosis of scleroderma
- Willing and able to provide written informed consent
- Use of experimental therapies within 28 days prior to Screening.
- Aspirin use > 81 mg daily within 1 week prior to Screening.
- Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study
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: NCT01881529
|St Vincent's Centre for Applied Medical Research
|Darlinghurst, New South Wales, Australia, 2010 |
||Bittoo Kanwar, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 5, 2013
||April 16, 2014
||Australia: Human Research Ethics Committee
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Connective Tissue Diseases
Esophageal Motility Disorders
Digestive System Diseases
Peripheral Vascular Diseases
Calcium Metabolism Disorders