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RecruitingNCT00005917Updated Aug 28, 2026

Study of Chediak-Higashi Syndrome

An observational study in Chediak-Higashi Syndrome, sponsored by National Human Genome Research Institute (NHGRI). Recruiting at 1 site in United States. Open to participants aged 1 Month to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by National Human Genome Research Institute (NHGRI) · Observational

From the registry’s dates

  • Started Sep 2002; still recruiting 24 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
1 Month to 70 Years
Sex
All
01

Study summary

Chediak-Higashi syndrome (CHS) is a rare autosomal recessive disorder characterized in its classical form by oculocutaneous albinism, a bleeding diathesis, recurrent infection due to abnormal neutrophil and natural killer cell function, and eventual progression to a lymphohistiocytic infiltration known as the accelerated phase . Death often occurs within the first decade as a result of infection or the development of the accelerated phase; bone marrow transplantation is curative except for the late occurrence of neurological deterioration. The basic defect is unknown, although it probably involves abnormal fusion or trafficking of intracellular vesicles. Patients with classical CHS have their disease due to mutations in the LYST gene, but mildly affected individuals have been reported whose genetic defect has not been defined. It is likely that these variants of CHS have abnormalities in proteins involved in the pathways responsible for vesicle fusion. Since the full clinical spectrum of CHS and its variants has not been characterized, and the underlying defects remain enigmatic, we plan to evaluate this group of patients clinically, biochemically, and molecularly, and perform cell biological studies on their fibroblasts, melanocytes, and transformed lymphoblasts. Routine admissions will be 5 days and may occur every two years, or required by changes in clinical symptomatology.

Read the detailed description

Chediak-Higashi syndrome (CHS) is a rare autosomal recessive disorder characterized in its classical form by oculocutaneous albinism, a bleeding diathesis, recurrent infection due to abnormal neutrophil and natural killer cell function, and often progression to a lymphohistiocytic infiltration known as the accelerated phase . Death generally occurs within the first decade as a result of infection or the development of the accelerated phase; bone marrow transplantation is curative except for the late occurrence of neurological deterioration. However, our research has identified mildly affected individuals who present primarily with a neurological phenotype characterized by central and peripheral nervous system involvement. In addition, classical cases treated with bone marrow transplant (BMT) and surviving into adulthood usually develop neurological symptoms adding relevance to the study of pathophysiology of this disease outside of the hematological and immune systems. The only gene known to be associated with CHS is LYST; however, there are some patients with CHS in whom mutations have not been found, suggesting locus heterogeneity. A genotype-phenotype correlation had begun to emerge, but recent reports noted exceptions to this correlation. The basic defect is unknown, although it probably involves abnormal fusion or trafficking of intracellular vesicles. With regards to neurologic involvement, LYST likely also plays a role in neuronal axonal transport and neurotransmitter pools. We plan to evaluate individuals with CHS clinically, biochemically, and molecularly, and perform cell biological studies on their fibroblasts, melanocytes, and transformed lymphoblasts. Routine admissions may be 3-5 days and may occur every one to two years, or as required by changes in clinical symptomatology.

02

Conditions studied

  • Chediak-Higashi Syndrome

Keywords

  • Albinism
  • Giant Granules
  • Infection
  • Melanosomes
  • Platelet Storage Pool Defect
  • Natural History
03

In context

Albinism

17 studies on the registry are indexed under Albinism; 8 are open to participants now.

This study's planned enrollment of 60 is below the median of 140 across 10 observational studies indexed under Albinism.

Browse Albinism studies →

Lead sponsor

National Human Genome Research Institute (NHGRI) is the lead sponsor of 203 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients entering this study will have clinical features suggestive of CHS. Objective evidence of a platelet storage pool deficiency (e.g., an abnormal secondary aggregation response or absent platelet dense bodies) or of a lysosomal fusion abnormality (e.g., giant cytoplasmic granules in leucocytes) will not be required.@@@

Eligibility criteria

  • ELIGIBILITY:

Patients will be between the age of 1 month and 70 years. All patients entering this study will have some degree of oculocutaneous albinism plus either a bleeding diathesis or a history of excessive infections in childhood. Objective evidence of a storage pool deficiency (e.g., an abnormal secondary aggregation response or absent platelet dense bodies) or of a lysosomal fusion abnormality (e.g., giant cytoplasmic granules in leucocytes) will not be required.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)

Groups and cohorts

  • Chediak-Higashi Syndrome

    Confirmed or suspected patients with Chediak-Higashi Syndrome.

06

What researchers measure

Primary outcomes

  1. Delineate the clinical and laboratory findings of CHS and its variants.

    Delineate the clinical and laboratory findings of CHS and its variants.

    Time frame: 4-5 days every 1-2 years

Secondary outcomes

  1. Mutation analysis of the LYST gene will be performed, to further delineate genotype/phenotype correlations and or locus heterogeneity.

    Mutation analysis of the LYST gene will be performed, to further delineate genotype/phenotype correlations and or locus heterogeneity.

    Time frame: 4-5 days every 1-2 years

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — This data will be deidentified.

Supporting information: Study protocol

Time frame: While the study is open.

Access criteria: All data sharing will be approved by the NHGRI Tech Transfer Office.

09

Timeline

Tracking since Sep 25, 2026

Started Sep 2002 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jun 16, 2000
First posted
Jun 19, 2000
StartActual
Sep 10, 2002
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00005917
Responsible party
Sponsor
First posted
Jun 19, 2000
Start date
Sep 10, 2002
Last update
Aug 28, 2026

Study contacts

Wendy J Introne, M.D.
Contact
wi2p@nih.gov
(301) 451-8879
Wendy J Introne, M.D.
principal investigator · National Human Genome Research Institute (NHGRI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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