Shwachman-Diamond Syndrome Registry and Study

This study is an observational registry for people with Shwachman-Diamond Syndrome (SDS) or SDS-Like conditions. SDS is a genetic condition affecting bone marrow, causing other health problems, and increasing leukemia risk. SDS-Like conditions have similar symptoms but without known genetic causes. Since these conditions are rare, this registry aims to collect information from medical records and biological samples to better understand SDS/SDS-Like diseases. The goal is to improve diagnosis, guide medical care, and develop better treatments. Success will be measured by understanding the natural history, complications, and treatment outcomes over 50 years, and by identifying new genes involved.

Study design
This is an observational study planning to enroll 5000 participants. It collects information and samples without specific interventions.
What's involved
The study collects information from your medical records and biological samples that are already being taken for your regular clinical care. No extra visits or procedures are needed.
Compensation
Not stated in the trial record.
Follow-up
The study aims to characterize the conditions and identify new genes over a 50-year period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06056908

Shwachman Diamond Syndrome Registry and Study

Recruiting
Not specifiedAll AgesObservational
Boston Children's Hospital
~5,000 participants
Updated 2026-04-06 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize the natural history, medical complications, and treatment outcomes for patients with SDS and SDS-Like conditions.
Measured over 50 years
+3 more outcomes measured
Shwachman-Diamond Syndrome
Shwachman-Diamond Syndrome-Like
4 sites across 3 states
Massachusetts2
Colorado1
Ohio1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Biallelic mutations in SBDS, or pathogenic mutations in DNAJC21, EFL1, or SRP54 OR
Shwachman-Diamond Syndrome defined clinically OR
Clinically suspected Shwachman-Diamond Syndrome OR
Phenotypic features suggestive of SDS OR
Parents, siblings, and other blood relatives of any age, living and deceased, of patients with SDS or SDS-Like conditions are eligible for this study
  • Characterize the natural history, medical complications, and treatment outcomes for patients with SDS and SDS-Like conditions.50 years

    The SDSR will collect clinical information regarding SDS and SDS-Like conditions. The goal is to understand the natural history, treatment outcomes and complications of these rare disorders in order to improve diagnosis, medical management, and treatment.

  • Investigate the molecular and genetic pathogenesis of SDS/SDS-Like condtions and their complications such as marrow failure and clonal evolution.50 years

    The SDSR will coordinate a repository of blood, cord blood, bone marrow, saliva, skin fibroblast, and tumor samples and cell lines from patients with SDS and SDS-Like conditions for basic science studies of molecular and genetic pathways causing these disorders and their complications. We will also study how genetic/molecular pathways may be targeted or corrected for the development of new therapies. To this end, we will create immortalized cell lines including EBV-transformed lymphoblasts, immortalized fibroblasts, and induced pluripotent stem cells. These cell lines will provide a renewable source of rare patient-derived material for these studies.

  • Identify new genes causing SDS/SDS-Like conditions50 years

    The SDSR will sequence DNA from patient samples to try to identify new genes that are involved in SDS/SDS-like phenotypes.

  • Provide education on the diagnosis, medical management, and treatment of SDS/SDS-Like conditions for patients, families, and the medical/scientific community.50 years

    The SDSR will disseminate information through the study website, conferences, and other scientific publications.