RecruitingNot Applicable

Deciphering the Genetic Architecture of Autoimmune Diseases

United States, Peru300 participantsStarted 2026-07-01

Plain-language summary

Background: Autoimmune diseases can be caused by genes people inherit from their parents. The gene changes that cause these diseases have been well studied in people with European and Asian ancestors. But some diseases behave differently in people who are native to North and South America. Researchers want to know more about the gene changes and other factors that may cause autoimmune diseases among these people. This project will be based in Peru. Objective: To study how gene changes can lead to autoimmune diseases in people native to Peru. Eligibility: People aged 18 years and older with an autoimmune disease. These may include systemic lupus erythematosus; Sjogren disease; scleroderma; rheumatoid arthritis; seronegative spondylo-arthropathies; and systemic vasculitis. Family members and healthy volunteers are also needed. Design: Participants will have 2 clinic visits; these will be 2 weeks apart. The clinics will be in Lima, Iquitos, and other sites in Peru. Visit 1: Participants will have a physical exam. They will answer questions about their health risks and habits. They will provide blood and urine samples. Visit 2: Participants will provide a second blood sample and a stool sample. They will talk about the results of their first clinical exam with researchers. The cost of travel to and from the clinics will be provided. Participants will get $30 per visit and a snack.

Who can participate

Age range

18 Years – 115 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

People diagnosed with a chronic viral disease: HIV, hepatitis C or HTLV-1.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial seems to focus on whole-genome sequencing rather than offering a new treatment — can you help me understand what, if anything, I might personally gain from participating, versus just contributing data to research?
2Since this study is listed as Phase NA, which often means it's an observational or genetic study rather than a drug trial, does participating in any way affect or delay my current treatment plan for my autoimmune condition?
3What would whole-genome sequencing actually involve for me practically — like blood draws, time commitment, or follow-up visits — and is that realistic given everything else I'm managing right now?
4If my genetic data reveals something unexpected or significant about my health, would I be told about those findings, and how would that information be handled or shared?
5Are there other genetic research studies or standard diagnostic genetic tests I should consider alongside or instead of this trial that might be more directly relevant to managing my specific autoimmune disease?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

whole-genome sequencing

Timeframe: Ongoing

Trial details

NCT IDNCT06948110

SponsorNational Human Genome Research Institute (NHGRI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2030-04-22

Contact for this trial

Cristina M Lanata, M.D.

(301) 451-2302 cristina.lanata@nih.gov

View on ClinicalTrials.gov More Autoimmune Diseases trials

Plain-language summary