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NTM CRISPR CFDNA

Overview

About this study

The purpose of this study is to conduct analytic and clinical validation of a CRISPR-based blood test for MAC cellfree DNA as a measure of MAC pulmonary disease activity and treatment response. This biomarker could ultimately be used to guide diagnostic and therapeutic decision-making with regard to MAC pulmonary disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

All cohorts – Inclusion/Exclusion Criteria

  • Age 18+

Retrospective Inclusion

  • Meet ATS/IDSA disease criteria for MAC-PD6 including the following:
    • At least 2 sputum or 1 bronchoalveolar lavage AFB culture positive for M. avium complex.
    • Respiratory symptoms o Nodular-bronchiectatic or cavitary disease on CT scan within prior 6 months.
  • Most recent positive culture within 12 weeks of blood draw.

Prospective Inclusion

  • Meet ATS/IDSA disease criteria for MAC-PD6 , including the following:
    • At least 2 sputum or 1 bronchoalveolar lavage AFB culture positive for M. avium complex o Respiratory symptoms.
    • Nodular-bronchiectatic or cavitary disease on CT scan within prior 6 months.
  • Initiating ATS/IDSA guideline-based anti-mycobacterial therapy for MAC pulmonary disease

Prospective Inclusion

  • Have completed multi-drug therapy for MAC-PD and be within 3 months of end of treatment.

Exclusion Criteria:

Prospective Exclusion

  • Human immunodeficiency virus (HIV).
  • Any history of organ transplant.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/30/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Aksamit, M.D.

Contact us for the latest status

Contact information:

Christopher Roberts

(507) 284-9946

Roberts.Christopher4@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20578871

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