90 Participants Needed

Biomarker Studies for Smith-Magenis Syndrome

DP
Overseen ByDavut Pehlivan, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find new ways to measure and understand RAI1-related disorders, such as Smith-Magenis syndrome and Potocki-Lupski syndrome. Researchers seek to discover biomarkers (biological indicators) that can aid in diagnosing these conditions, tracking their progress, and distinguishing them from each other. Participants will undergo various assessments, including clinical exams, a blood draw, and possibly a sleep study, to gather this information. Individuals with an RAI1-related disorder confirmed by genetic testing and who can travel to Houston for a day may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to improved diagnostic tools and treatments for RAI1-related disorders.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover valuable insights into RAI1-related disorders, which are currently not well-understood. Unlike traditional treatments that often aim to manage symptoms, this study focuses on identifying clinical and molecular biomarkers that could revolutionize diagnosis and treatment strategies in the future. By comparing patients with RAI1-related disorders to healthy family members, the trial may reveal unique biomarkers that could lead to more targeted and effective therapies. This approach holds promise for advancing personalized medicine and improving outcomes for individuals with these rare conditions.

Who Is on the Research Team?

DP

Davut Pehlivan, MD

Principal Investigator

Texas Children's Hospital - Baylor College of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

My genetic test confirmed I have an RAI1-related disorder.
I am between 1 month and 60 years old.
I can travel to the study site and spend a day in Houston.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical Assessment

Participants undergo clinical examination, blood draw, optional skin biopsy, and sleep study

1 visit (overnight stay for selected individuals)
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessments

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Patient groupExperimental Treatment3 Interventions
Group II: Control groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Doris Duke Charitable Foundation

Collaborator

Trials
65
Recruited
264,000+