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Web-based Genetic Research on Lupus

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ClinicalTrials.gov Identifier: NCT02530944
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
23andMe, Inc.

Brief Summary:
The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.

Condition or disease
Systemic Lupus Erythematosus

Detailed Description:
Lupus is a difficult disease to diagnose and one that's difficult to manage, given the lack of specific medicines to treat lupus and the side-effects of current medications. The investigators believe genetics may play a critical role in developing better lupus diagnoses and treatments. If individuals are eligible to participate, the investigators will send a 23andMe DNA saliva kit at no cost. Participants will be asked to take a 15 minute online survey with questions about their lupus experience, symptoms and response to treatments, in addition to five additional bi-monthly short surveys and one final study survey during the 12-month participation. Learn more and join the lupus study today: https://www.23andme.com/lupus/

Study Type : Observational
Actual Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2015
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Group/Cohort
Lupus patients
People diagnosed with Systemic Lupus Erythematosus by a physician



Primary Outcome Measures :
  1. Salivary DNA sample for genetic analysis [ Time Frame: 12 months ]
  2. Online survey [ Time Frame: 12 months ]
    Questions about lupus experience, symptoms and response to treatment


Biospecimen Retention:   Samples With DNA
Saliva samples are collected for DNA analysis


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

Inclusion Criteria:

  • diagnosed with lupus by a qualified physician.
  • consents to have 23andMe (via a partner) contact the physician to obtain medical record information
  • willing to submit a saliva sample for DNA testing and complete online surveys related to condition
  • at least 6 years old (minors under 18 require parental consent to enroll)
  • access to the internet
  • resides in the United States

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530944


Locations
United States, California
Www.23Andme.Com/Lupus
Mountain View, California, United States, 94041
Sponsors and Collaborators
23andMe, Inc.
Pfizer

Responsible Party: 23andMe, Inc.
ClinicalTrials.gov Identifier: NCT02530944     History of Changes
Other Study ID Numbers: 23andMe_SLE001
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Keywords provided by 23andMe, Inc.:
Lupus
Systemic Lupus Erythematosus (SLE)
genetic
online
genome wide association
systemic lupus erythematosus
genome wide association study (GWAS)

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