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. 2023 Mar 22;23(1):97.
doi: 10.1186/s12890-023-02329-3.

UMOYA: a prospective longitudinal cohort study to evaluate novel diagnostic tools and to assess long-term impact on lung health in South African children with presumptive pulmonary TB-a study protocol

Isabelle Dewandel  1 , Margaret van Niekerk  1 , Elisabetta Ghimenton-Walters  1   2 , Megan Palmer  1 , Michaile G Anthony  1 , Carla McKenzie  1 , Rolanda Croucamp  1 , Galit Alter  3   4 , Anne-Marie Demers  1   5   6 , Gert van Zyl  7   8 , Mathilda Claassen  7 , Pierre Goussard  9 , Ruan Swanepoel  10 , Graeme Hoddinott  1 , Corne Bosch  1 , Rory Dunbar  1 , Brian Allwood  11 , Eric D McCollum  1   12 , H Simon Schaaf  1 , Anneke C Hesseling  1 , Marieke M van der Zalm  13
Affiliations

UMOYA: a prospective longitudinal cohort study to evaluate novel diagnostic tools and to assess long-term impact on lung health in South African children with presumptive pulmonary TB-a study protocol

Isabelle Dewandel et al. BMC Pulm Med. .

Abstract

Background: Despite a high paediatric tuberculosis (TB) burden globally, sensitive and specific diagnostic tools are lacking. In addition, no data exist on the impact of pulmonary TB on long-term child lung health in low- and middle-income countries. The prospective observational UMOYA study aims (1) to build a state-of-the-art clinical, radiological, and biological repository of well-characterised children with presumptive pulmonary TB as a platform for future studies to explore new emerging diagnostic tools and biomarkers for early diagnosis and treatment response; and (2) to investigate the short and long-term impact of pulmonary TB on lung health and quality of life in children.

Methods: We will recruit up to 600 children (0-13 years) with presumptive pulmonary TB and 100 healthy controls. Recruitment started in November 2017 and is expected to continue until May 2023. Sputum and non-sputum-based samples are collected at enrolment and during follow-up in TB cases and symptomatic controls. TB treatment is started by routine care services. Intensive follow-up for 6 months will allow for TB cases to retrospectively be classified according to international consensus clinical case definitions for TB. Long-term follow-up, including imaging, comprehensive assessment of lung function and quality of life questionnaires, are done yearly up to 4 years after recruitment.

Discussion: The UMOYA study will provide a unique platform to evaluate new emerging diagnostic tools and biomarkers for early diagnosis and treatment response and to investigate long-term outcomes of pulmonary TB and other respiratory events on lung health in children.

Keywords: Biomarkers; Biorepository; Cohort; Lung function; Lung health; Paediatric pulmonary tuberculosis; Post-TB health; Quality of life; South Africa; Study protocol.

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Conflict of interest statement

Galit Alter is an employee of Moderna Therapeutics and an equity holder in Leyden Labs and Seromyx Systems, only after study set-up and enrolment. All other authors declare that they have no competing interests. This study has received multiple awards which are reported under the funding section.

Figures

Fig. 1
Fig. 1
Flow diagram of study participants. Flow diagram of children enrolled in the study and followed for 4 years. *Children initially enrolled as symptomatic control are clinically checked throughout the study and if there is a clinical suspicion of tuberculosis can move to the TB cases group. TB: Tuberculosis; QoL: Quality of life
See this image and copyright information in PMC

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