NCT01230112

Brief Summary

Study to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

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

Study Start

First participant enrolled

December 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2.3 years

First QC Date

October 27, 2010

Last Update Submit

July 29, 2013

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal Control Subjects with genotype of interest registered in the Genotype and Phenotype Registry

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and DNA will be collected and retained

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2010

First Posted

October 28, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

US(1)