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Trial record 1 of 1 for:    NCT02530944
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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.

Tracking Information
First Submitted Date August 18, 2015
First Posted Date August 21, 2015
Last Update Posted Date January 10, 2018
Study Start Date May 2015
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2015)
  • Salivary DNA sample for genetic analysis [ Time Frame: 12 months ]
  • Online survey [ Time Frame: 12 months ]
    Questions about lupus experience, symptoms and response to treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Web-based Genetic Research on Lupus
Official Title Not Provided
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva samples are collected for DNA analysis
Sampling Method Non-Probability Sample
Study Population Community Sample
Condition Systemic Lupus Erythematosus
Intervention Not Provided
Study Groups/Cohorts Lupus patients
People diagnosed with Systemic Lupus Erythematosus by a physician
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 20, 2015)
5000
Original Estimated Enrollment Same as current
Actual Study Completion Date October 31, 2017
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02530944
Other Study ID Numbers 23andMe_SLE001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party 23andMe, Inc.
Study Sponsor 23andMe, Inc.
Collaborators Pfizer
Investigators Not Provided
PRS Account 23andMe, Inc.
Verification Date January 2018