Prospective Analysis of Urine LAM to Eliminate NTM Sputum Screening

N/AEnrolling By InvitationNCT04579211

Jerry A. Nick, M.D.220 enrolled

Overview

This is a prospective, single-center, nonrandomized observational study to investigate the utility of urine lipoarabinomannan (LAM) as a test to identify individuals at very low risk for having a sputum culture positive for Nontuberculous Mycobacteria (NTM). The study is designed to evaluate if a urine test can eliminate the need for obtaining a sputum specimen to screen for NTM in individuals with Cystic Fibrosis (CF). The participants will be asked to provide 3 urine samples either in person or by mail over approximately 3 years. The 3 urine sample requests will be timed to coincide with their usual clinical care and routine sputum collection.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Cystic Fibrosis

Interventions

urine lipoarabinomannan (LAM)DIAGNOSTIC_TEST

Investigate the utility of urine LAM as a test to identify individuals at very low risk for having a sputum culture positive for NTM.

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent obtained online or in person from the participant * Enrolled in the CFF Patient Registry (CFFPR) * Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements * Diagnosis of CF consistent with the 2017 CFF Guidelines NTM culture status of negative (defined by a review of clinical and culture data with at least 3 years of clinical data available to review and at least one negative culture within the year prior to enrollment and no known history of previous positive cultures for pathogenic NTM) Exclusion Criteria: 1\. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Outcomes

Primary Outcomes

To determine the ability of the urine LAM assay to predict continued negative sputum culture over the next 12 months.

Correlation of a negative NTM sputum culture in the year following a negative urine LAM assay

Time frame: From time enrollment to over the next 12 months

Secondary Outcomes

To determine the ability of the urine LAM assay to predict new positive NTM sputum culture over the next 12 months.

Correlation of a positive NTM sputum culture in the year following a positive urine LAM assay

Time frame: From time of enrollment to over the next 12 months

To determine the time between a positive LAM assay and a new positive NTM culture.

Correlation of a positive NTM sputum culture up to 3 years following a positive urine LAM assay

Time frame: 3 years

To facilitate the development of a ELISA-based assay as a possible replacement to GC/MS in the clinical setting.

Excess urine will be used to develop and validate an alternative assay using ELISA.