Status:

ENROLLING_BY_INVITATION

Research for Individualized Therapeutics in Rare Genetic Disease

Lead Sponsor:

Mayo Clinic

Conditions:

Rare Genetic Disease

Undiagnosed Diseases

Eligibility:

All Genders

Brief Summary

The purpose of this research study is to identify individuals that have a rare genetic disease without an adequate therapeutic strategy that might be treatable with drug developed to target the diseas...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Has Mayo Clinic or other medical health system ID, or another unique identifier.
  • Able to provide informed consent.
  • Individual must have evidence of a genetic disorder as determined by a provider or genetic counselor with causative or likely causative genetic variants identified by molecular testing.
  • Genetic variants must be hypothesized to be targetable using antisense oligonucleotide drugs (such as: knockdown gain of function alterations, increase protein production for reduced function alterations, or modulate mRNA splicing to correct abnormal splicing, promote normal splicing, or return reading frame to an out-of-frame transcript to restore function, etc.) based on current acceptable understanding of ASO mechanisms of action and tissue/organ targeting efficiency.
  • Biological family member of an enrolled individual.
  • Would be able to travel to a Mayo Clinic site for ongoing treatment should a therapeutic be developed.
  • Treatment at the individual's current disease state would likely provide benefit based on current clinical data and understanding of the progression of the disease.
  • Or-
  • Biological family member of an enrolled individual
  • Able to provide informed consent or has a LAR available to provide informed consent
  • Exclusion Criteria
  • Individuals who have situations that would limit compliance with the study requirements.
  • Institutionalized (i.e. Federal Medical Prison).

Exclusion

    Key Trial Info

    Start Date :

    November 24 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2026

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT05236595

    Start Date

    November 24 2021

    End Date

    November 1 2026

    Last Update

    February 21 2025

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Mayo Clinic in Arizona

    Scottsdale, Arizona, United States, 85259

    2

    Mayo Clinic Florida

    Jacksonville, Florida, United States, 32224

    3

    Mayo Clinic Rochester

    Minneota, Minnesota, United States, 55905

    Research for Individualized Therapeutics in Rare Genetic Disease | DecenTrialz