Actively Recruiting

All Genders
ID03789721

Adrenoleukodystrophy National Registry Study

Led by Masonic Cancer Center, University of Minnesota · Updated on 2026-05-12

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, observational registry study on Adrenoleukodystrophy (ALD), including patients with confirmed or presumed ALD mutations. The study aims to understand the natural history, disease progression, and outcomes in affected individuals, including children, adolescents, adults, and women with ALD. The research also seeks to develop biomarkers from collected biospecimens to potentially predict disease progression and support future interventions. Participants provide medical histories and allow collection of various biospecimens such as buccal swabs, blood, stool, and urine samples, which are stored in a biorepository. The study collects clinical and epidemiological data through medical record reviews and self-reported questionnaires every six months. Eligible participants include those diagnosed by newborn screening, family history, or other means and those with confirmed or presumed mutations. During the study, participants may be asked to provide longitudinal samples and medical information over a period of up to 10 years. Researchers monitor clinical data to better understand disease progression and gather valuable biological data. The registry and biorepository serve as resources for ongoing and future ALD research, supporting efforts to identify prognostic markers and improve patient care.

CONDITIONS

Brief Title

Adrenoleukodystrophy National Registry Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 0 to 100 years
  • Diagnosed with ALD confirmed by positive VLCFA testing or genetic mutation
  • Known or presumed ALD mutation based on family history or confirmed mutation in ABCD1 gene
  • Living in the United States or its territories
Not Eligible

You will not qualify if you...

  • Lack capacity to consent or assent without a legally authorized representative or guardian
  • Have undergone bone marrow transplant or other cellular therapy
  • Not fluent in English and unable to consent in person at the BMT Journey Clinic
  • Illiterate
  • Considered unlikely to complete study requirements due to language barriers or compliance issues

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surveillance

Duration - Up to 10 years

Participants are observed over time to collect clinical and epidemiological data related to Adrenoleukodystrophy (ALD).

Semi-annual visits for data collection and questionnaires

Sample Collection

Duration - Ongoing during study participation

Participants provide biospecimen samples such as buccal swab, blood, stool, and urine when feasible for research purposes.

Sample collection occurs during visits as feasible

Trial Site Locations

Total: 1 location

1

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

A

Ashish Gupta, MD

P

Paul Orchard, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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