Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Role of ITGAM in Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Northwell Health
ClinicalTrials.gov Identifier:
NCT01230112
First received: October 27, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose
Study to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene.

Condition
Systemic Lupus Erythematosus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: TAP0307.6: Sub-study of TAP 0307- Enrollment of Normal Controls to Study the Role of ITGAM in Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Biospecimen Retention:   Samples With DNA
Blood and DNA will be collected and retained

Enrollment: 40
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal Control Subjects with genotype of interest registered in the Genotype and Phenotype Registry
Criteria

Inclusion Criteria:

  • males and females, age 18 or older, enrolled in Genotype and Phenotype Registry, in general good health
  • Participants who carry the genotype of interest, based on a buccal or blood derived DNA sample

Exclusion Criteria:

  • History of Systemic Lupus Erythematosus, rheumatoid arthritis, or other autoimmune disease
  • History of cancer or lymphoma
  • Current use of aspirin, prednisone, or NSAID or any immunosuppressant
  • Self reported HIV
  Contacts and Locations
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: NCT01230112

Locations
United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01230112     History of Changes
Other Study ID Numbers: 09-289 
Study First Received: October 27, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 08, 2016