Clinical proteomics: A need to define the field and to begin to set adequate standards

Abstract

The aim of this manuscript is to initiate a constructive discussion about the definition of clinical proteomics, study requirements, pitfalls and (potential) use. Furthermore, we hope to stimulate proposals for the optimal use of future opportunities and seek unification of the approaches in clinical proteomic studies. We have outlined our collective views about the basic principles that should be considered in clinical proteomic studies, including sample selection, choice of technology and appropriate quality control, and the need for collaborative interdisciplinary efforts involving clinicians and scientists. Furthermore, we propose guidelines for the critical aspects that should be included in published reports. Our hope is that, as a result of stimulating discussion, a consensus will be reached amongst the scientific community leading to guidelines for the studies, similar to those already published for mass spectrometric sequencing data. We contend that clinical proteomics is not just a collection of studies dealing with analysis of clinical samples. Rather, the essence of clinical proteomics should be to address clinically relevant questions and to improve the state-of-the-art, both in diagnosis and in therapy of diseases.

A Distinct Urinary Biomarker Pattern Characteristic of Female Fabry Patients That Mirrors Response to Enzyme Replacement Therapy

“…However, none of the above mentioned studies validated their results in an independent cohort. Given the large number of peptides being simultaneously detected using proteomic techniques, vigorous adjustment for multiple testing and validation of the results in an independent cohort are of particular importance [20]. Our study is, to our knowledge, the first proteomic study in Fabry disease, which compares both, treatment-naïve and ERT treated patients to healthy controls and validated the results in an independent cohort.…”

Urinary Proteomics in Diabetes and CKD

“…24 All urine samples for CE-MS analyses were from spontaneously voided urine and stored at Ϫ80°C until analysis. Sample preparation and CE-MS analysis were performed.…”

How Shall We Use the Proteomics Toolbox for Biomarker Discovery?

“…This restricted frame implies in turn that the discussion on what is a biomarker is outside the scope of this paper. As a matter of facts, this issue has also been reviewed recently in the frame of proteomics studies 2 Because of their easy accessibility compared to tissue biopsies, biological fluids are targets of choice for looking for diagnostic, prognostic and even treatment follow up biomarkers. The paradigm is that the tissues, which are in contact with biological fluids, are prone to liberate protein components in the fluids, and that the disease-altered state will change either the spectrum or the amount of liberated proteins.…”