cell free DNA for Sarcoidosis

1
Effectiveness
1
Safety
University of Iowa, Iowa City, IA
Sarcoidosis+6 More
cell free DNA - DiagnosticTest
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

Cell Free DNA in Cardiac Sarcoidosis

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Eligible Conditions

  • Sarcoidosis
  • Myocardial Infarction
  • Infarction
  • ST Elevation Myocardial Infarction
  • Carditis
  • Sarcoidosis With Myocarditis
  • Healthy Subjects (HS)
  • Myocarditis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether cell free DNA will improve 1 primary outcome in patients with Sarcoidosis. Measurement will happen over the course of cfDNA level at baseline and 2 months for sarcoidosis with heart disease compared to cfDNA levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfDNA levels at baseline, 6 and 24 hours for STEMI patients..

Month 2
cfDNA level

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

Sarcoidosis patients without evidence of active myocarditis
Sarcoidosis patients with evidence of active myocarditis
Placebo group

This trial requires 120 total participants across 4 different treatment groups

This trial involves 4 different treatments. Cell Free DNA is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Sarcoidosis patients with evidence of active myocarditis
DiagnosticTest
Two blood draws 2 months apart.
Sarcoidosis patients without evidence of active myocarditis
DiagnosticTest
A single blood draw.
Healthy controls
DiagnosticTest
A single blood draw
Acute ST elevation myocardial infarction (STEMI)
DiagnosticTest
Three blood draws, baseline, 6 hours and 24 hours.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: cfdna level at baseline and 2 months for sarcoidosis with heart disease compared to cfdna levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfdna levels at baseline, 6 and 24 hours for stemi patients.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly cfdna level at baseline and 2 months for sarcoidosis with heart disease compared to cfdna levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfdna levels at baseline, 6 and 24 hours for stemi patients. for reporting.

Closest Location

University of Iowa - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of sarcoidosis based on the ATS/ERS criteria.
Normal 12 lead ECG within the past one year.
Non-smoker.
No immunosuppressive therapy for at least one year.
Known cardiac disease.
Active smoker.
On immunosuppressive therapy.
Evidence of active myocarditis based on recent cMRI or cFDG-PET.
Known cardiac disease other than sarcoidosis.
Diagnosis STEMI based on 1mm ST elevation in 2 or more contiguous leads.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can sarcoidosis be cured?

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Sarcoidosis is not curable. Sarcoidosis patients have a risk of developing other diseases. However, patients with sarcoidosis have a good chance of not developing other diseases and avoiding disability of their lives. Patients who are young, healthy, and who have sarcoidosis and no other disease can be reassured that their disease will not progress to the point that their lives are in danger.

Unverified Answer

What are common treatments for sarcoidosis?

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Results from a recent clinical trial, topical and systemic corticosteroid were found effective in treating some patients with sarcoidosis. However, corticosteroids were not found as effective as in reports made previously. Results from a recent clinical trial should be examined in larger, prospective studies.

Unverified Answer

What are the signs of sarcoidosis?

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Individuals with sarcoidosis may find it difficult to control their symptoms. Often symptoms develop when symptoms are not present at onset of the disease. One may also not associate the disease with symptoms, or may discount them. People should be aware that the disease can develop chronic symptoms with eventual complications. Sarcoidosis may cause pain in the eyes, swelling or changes in the skin. Some symptoms, especially coughing, can be hard to explain. One may also expect abnormal liver function tests.

Unverified Answer

How many people get sarcoidosis a year in the United States?

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About 3 million people per year in the United States have sarcoidosis. This makes it the most common cause of lymphadenopathy, bronchial insufficiency and pulmonary disease in American adults.

Unverified Answer

What is sarcoidosis?

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Recent findings of the present investigation suggest that sarcoidotic lung involvement has a high prevalence and is characterized by prominent granulomatous changes. This information might be helpful in planning surgical treatment.

Unverified Answer

What causes sarcoidosis?

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If sarcoidosis is of autoimmune origin, then a number of potential antigens are presently being studied. If sarcoidosis is infectious in origin, then exposure to particular pathogens could be the cause of sarcoidosis. The diagnosis of sarcoidosis is often made without definite knowledge of how it is caused, and therefore, clinical research is required to establish causation in this heterogenous disease.

Unverified Answer

What is the average age someone gets sarcoidosis?

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According to a recent study by the Center for Disease Control and Prevention, the average age a person encounters sarcoidosis is about 34 years old, which can't be too early for the ailment to arise. However, the average patient must have an occupational hazard for the disease. It is still a possibility that sarcoidosis could be caused by a virus or a chemical. The cause will most likely be established in the near future when further knowledge of sarcoidosis is found.

Unverified Answer

Is cell free dna typically used in combination with any other treatments?

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As yet, CFFD is not being used in combination with other modalities to create any specific treatment plan. However, CFFD may be used in conjunction with other therapies for some sarcoidosis cases. Recent findings provides preliminary insight for future evaluations in this field, although these findings need to be carefully extended in a larger, multicenter randomized study.

Unverified Answer

What is cell free dna?

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Cell-free DNA from peripheral blood mononuclear cells and granulocyte-macrophage colony-stimulating factor (GM-CSF) were obtained. Both DNA from sarcoidosis patients and normal subjects demonstrated the presence of several DNA motifs.

Unverified Answer

How serious can sarcoidosis be?

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Sarcoidosis is a disease with a heterogeneous presentation, ranging from asymptomatic/minimal to severe/fulminant disease. If we could identify patients with sarcoidosis who have severe disease with the intention to improve clinical outcomes and to determine long-term disease outcomes, sarcoidosis might become more manageable.

Unverified Answer

Who should consider clinical trials for sarcoidosis?

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Clinical trials can have significant impact; however, the best patients are those with disabling symptoms without response to therapy. A combination of therapies may help keep patients from developing chronic or refractory symptoms.

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What are the common side effects of cell free dna?

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Many patients were suffering from one or more of the common adverse effects of intravenous immunoglobulin. These include headache, itchiness, dizziness, fever and chills, nausea, pain in groin or beneath the skin or muscle, flu-like, and a decreased red blood pressure.

Unverified Answer
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