About this Research Topic
Trypanosoma cruzi (T. cruzi) infection is dynamic and involves a multiclonal population of parasites. Polymerase chain reaction (PCR) to measure T. Cruzi DNA (as a surrogate of parasite presence in blood) is useful to assess treatment failure. Despite that the PCR method is well-validated and can measure very low densities of parasites, the technique has clear limitations:
1. T. cruzi is predominantly located in tissues and its presence in blood is accidental. Therefore, the main limitation of PCR is not linked to its sensitivity but to the probability of finding a parasite in blood
2. qPCR values are often close to the limit of detection or below, and only a fraction of qPCR positive samples has values above the limit of quantification
3. PCR positivity could depend on the patient’s population
The goal pursued in this research topic is to determine the potential utility of PCR to quantitate T. cruzi parasite densities in blood as a measure of the therapeutic response in Chagas disease. Furthermore, to provide a critical review of the usefulness of polymerase chain reaction in Chagas disease, by focusing on following aspects:
• Natural history of parasitaemia in Chagas disease
• Review, analysis of clinical and preclinical data
• Review, analysis of the PCR methodology, sensitivity-specificity, quality assurance, standardization
• Review, analysis of the impact of the Discrete Typing Units and the molecular genotyping
• Use of pharmacometrics studies to optimize clinical design
• Correlation between PCR short-term and long-term responses
The main scope of this research topic will focus on the PCR methodology (standardization, validation, protocols, geographical variations, DTU’s, commercial kit, quantification of T. cruzi, etc...), the use of PCR in clinical studies (proof of concept and phase 3 trials), the use of PCR in animal models or in preclinical studies, the use of pharmacometrics tools, and the regulatory acceptance of the PCR technique for Chagas disease.
In this perspective, we welcome the submissions of Reviews (i.e. review of preclinical data, use of PCR in animal models), Perspective, Clinical Trial (i.e. observational and clinical studies) and Original Research articles.
1. T. cruzi is predominantly located in tissues and its presence in blood is accidental. Therefore, the main limitation of PCR is not linked to its sensitivity but to the probability of finding a parasite in blood
2. qPCR values are often close to the limit of detection or below, and only a fraction of qPCR positive samples has values above the limit of quantification
3. PCR positivity could depend on the patient’s population
The goal pursued in this research topic is to determine the potential utility of PCR to quantitate T. cruzi parasite densities in blood as a measure of the therapeutic response in Chagas disease. Furthermore, to provide a critical review of the usefulness of polymerase chain reaction in Chagas disease, by focusing on following aspects:
• Natural history of parasitaemia in Chagas disease
• Review, analysis of clinical and preclinical data
• Review, analysis of the PCR methodology, sensitivity-specificity, quality assurance, standardization
• Review, analysis of the impact of the Discrete Typing Units and the molecular genotyping
• Use of pharmacometrics studies to optimize clinical design
• Correlation between PCR short-term and long-term responses
The main scope of this research topic will focus on the PCR methodology (standardization, validation, protocols, geographical variations, DTU’s, commercial kit, quantification of T. cruzi, etc...), the use of PCR in clinical studies (proof of concept and phase 3 trials), the use of PCR in animal models or in preclinical studies, the use of pharmacometrics tools, and the regulatory acceptance of the PCR technique for Chagas disease.
In this perspective, we welcome the submissions of Reviews (i.e. review of preclinical data, use of PCR in animal models), Perspective, Clinical Trial (i.e. observational and clinical studies) and Original Research articles.
Keywords: Biomarker, Clinical trials, Discrete Typing Units, Endpoint, Pharmacometrics, Preclinical models, Quantitative Polymerase Chain Reaction, Trypanosoma cruzi
Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.
