Deciphering the Genetic Architecture of Autoimmune Diseases
Study explores genetic roots of autoimmune diseases in Peruvians.
Plain English Summary
Deciphering the Genetic Architecture of Autoimmune Diseases is a Not Applicable clinical trial sponsored by National Human Genome Research Institute (NHGRI) studying Autoimmune Diseases. This study investigates how inherited genes might cause autoimmune diseases, focusing on people native to Peru. It is looking for individuals aged 18 and older who have been diagnosed with specific autoimmune diseases, as well as their family members and healthy volunteers. Participation involves two clinic visits about two weeks apart for physical exams, questionnaires, and providing blood, urine, and stool samples. Alternatives include standard medical care for autoimmune conditions, but this study offers a unique opportunity to contribute to genetic research. The trial aims to enroll 300 participants.
Official 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
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with conditions like lupus, Sjogren's disease, scleroderma, rheumatoid arthritis, or certain types of vasculitis. Family members of patients and healthy volunteers aged 18 and older are also welcome. You cannot join if you have been diagnosed with a chronic viral disease such as HIV, hepatitis C, or HTLV-1. This trial is studying Autoimmune Diseases, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
Whole-genome sequencing means researchers will look at all of your genes to find tiny differences that might be linked to autoimmune diseases. The specific primary outcome measures are: whole-genome sequencing (Ongoing). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to uncover genetic factors contributing to autoimmune diseases in underrepresented populations, potentially leading to more targeted treatments. This research targets Autoimmune Diseases, where improved treatment options are needed.
Investor Insight
This observational study, while not directly developing a new drug, contributes valuable data to understanding disease origins, which can inform future drug development and market strategies for autoi
Is This Trial Right for Me?
Ask your doctor if participating in this genetic study aligns with your current treatment plan. Be prepared for two clinic visits, which include physical exams and providing samples; travel costs will be covered, and you'll receive a small payment and a snack. Your participation helps advance scientific understanding of autoimmune diseases in a specific population. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 300 participants
Primary Outcomes
- whole-genome sequencing (Ongoing)
Full Eligibility Criteria
* INCLUSION CRITERIA: Any person who meets the criteria for inclusion in the study will be considered and must have the patient's signed informed consent for participation. Autoimmune Disease Diagnosis: Cases: * Patients diagnosed with SLE, Sjogren's disease, scleroderma, rheumatoid arthritis, seronegative spondyloarthropathies, and systemic vasculitis, as defined by the American College of Rheumatology classification criteria. * Over 18 years old Controls: * Family members of identified cases, and unrelated individuals. The controls would be from the same community as the patients and families studied, and of the same age and gender. Screening for autoimmune diseases and allergic diseases will be performed. * Over 18 years old EXCLUSION CRITERIA: -People diagnosed with a chronic viral disease: HIV, hepatitis C or HTLV-1.
Trial Locations
- National Human Genome Research Institute (NHGRI), Bethesda, Maryland, United States
- Amazon Rainforest, Lima, Peru
Frequently Asked Questions
What is clinical trial NCT06948110?
NCT06948110 is a Not Applicable OBSERVATIONAL study titled "Deciphering the Genetic Architecture of Autoimmune Diseases." It is currently recruiting and is sponsored by National Human Genome Research Institute (NHGRI). The trial targets enrollment of 300 participants.
What conditions does NCT06948110 study?
This trial investigates treatments for Autoimmune Diseases. The primary condition under study is Autoimmune Diseases.
What does Not Applicable mean for NCT06948110?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06948110?
This trial is currently "Recruiting." It started on 2026-04-05. The estimated completion date is 2030-04-22.
Who is sponsoring NCT06948110?
NCT06948110 is sponsored by National Human Genome Research Institute (NHGRI). The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06948110?
The trial aims to enroll 300 participants. The trial is currently recruiting and accepting new participants.
How is NCT06948110 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06948110?
The primary outcome measures are: whole-genome sequencing (Ongoing). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06948110 being conducted?
This trial is being conducted at 2 sites, including Bethesda, Maryland; Lima (United States, Peru).
Where can I find official information about NCT06948110?
The official record for NCT06948110 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06948110. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06948110 testing in simple terms?
This study investigates how inherited genes might cause autoimmune diseases, focusing on people native to Peru. It is looking for individuals aged 18 and older who have been diagnosed with specific autoimmune diseases, as well as their family members and healthy volunteers.
Why is this trial significant?
This trial is important because it aims to uncover genetic factors contributing to autoimmune diseases in underrepresented populations, potentially leading to more targeted treatments.
What are the potential risks of participating in NCT06948110?
The primary risks are minimal and related to blood draws, such as bruising or minor discomfort. Potential side effects from providing samples are unlikely, but as with any medical procedure, there's a small risk of infection. The study involves sharing genetic information, which is anonymized but contributes to a larger dataset. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06948110?
Ask your doctor if participating in this genetic study aligns with your current treatment plan. Be prepared for two clinic visits, which include physical exams and providing samples; travel costs will be covered, and you'll receive a small payment and a snack. Your participation helps advance scientific understanding of autoimmune diseases in a specific population. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06948110 signal from an investment perspective?
This observational study, while not directly developing a new drug, contributes valuable data to understanding disease origins, which can inform future drug development and market strategies for autoi This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves two clinic visits about two weeks apart for physical exams, questionnaires, and providing blood, urine, and stool samples. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.