Registry for rare histiocytic disorders

International Rare Histiocytic Disorders Registry (IRHDR)

This study is gathering information from people of all ages with rare histiocytic disorders to help improve diagnosis and treatment options.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Sex: All
• Sponsor: The Hospital for Sick Children (Academic / other)
• Locations: 15 sites (Birmingham, Alabama and 14 other locations)
• Trial ID: NCT02285582 on ClinicalTrials.gov

What this trial studies

The International Rare Histiocytic Disorders Registry (IRHDR) aims to collect and analyze clinical, epidemiological, treatment, and survival data for patients diagnosed with rare histiocytic disorders. This observational registry will facilitate uniform diagnosis and provide a framework for future therapeutic recommendations. It includes patients of any age with a confirmed diagnosis of a rare histiocytic disorder, allowing for the inclusion of historical cases dating back to 1995. The registry will also offer expert pathology reviews to enhance understanding and management of these conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals of any age diagnosed with a rare histiocytic disorder, with suitable pathology samples available for review.

Not a fit: Patients without a confirmed diagnosis of a rare histiocytic disorder or those lacking a pathology sample for review may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could lead to improved diagnosis and treatment recommendations for patients with rare histiocytic disorders.

How similar studies have performed: While the approach of creating a registry for rare diseases is not novel, the specific focus on rare histiocytic disorders is relatively untested, highlighting the need for this initiative.

Eligibility criteria

Inclusion Criteria:

1. Any age at diagnosis.
2. Diagnosis of a rare histiocytic disorder, established before or after the opening of the registry.
3. Cases diagnosed from January - 01- 1995 until the present time and prospectively.
4. Signed informed consent by a patient, or parent/legal guardian.
5. Cognitively impaired patients can be included after consent by legal guardian/parent.
6. Deceased patients can be included if they are contacted at least 6 months after the death of their child and not on their child's birthday or anniversary of death.

Exclusion Criteria:

1. Informed consent has not been signed.
2. Diagnosis other than RHD.
3. Cases diagnosed before the year 1995.

Where this trial is running

Birmingham, Alabama and 14 other locations

• The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Children's Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
• Valley Children's Hospital — Madera, California, United States (Recruiting)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
• Hospital Nacional de Pediatria Garrahan — Buenos Aires, Argentina (Recruiting)
• The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
• Centre hospitalier universitaire Sainte-Justine — Montreal, Quebec, Canada (Active_not_recruiting)
• University Hospital Brno — Brno, Czechia (Recruiting)
• Rostock University Medical Hospital — Rostock, Germany (Recruiting)
• Azienda Ospedaliero-Universitaria Meyer — Florence, Italy (Recruiting)
• Prinses Maxima Center — Utrecht, Cs, Netherlands (Recruiting)
• Children's Memorial Health Institute — Warsaw, Poland (Recruiting)
• Hospital Universitario Cruces — Barakaldo, Spain (Recruiting)

Study contacts

• Principal investigator: Oussama Abla, MD — The Hospital for Sick Children
• Study coordinator: Oussama Abla, MD

Conditions Rare Histiocytic Disorders; Erdheim-Chester Disease; Rosai-Dorfman Disease; Xanthogranuloma Family; Indeterminate Dendritic Cell Histiocytosis; Malignant Histiocytic Neoplasm; ALK-positive Histiocytosis; Mixed Histiocytosis