Three key components of systemic sclerosis (SSc) are the subject of an ongoing clinical trial in University Hospital in Strasbourg, France. “Metabolomic Analysis of Systemic Sclerosis (SCLEROMICS)” is investigating prognosis, diagnosis, and exploratory research in SSc. Current knowledge in the field lacks a system of diagnostic and prognostic markers for SSc, along it is known that the condition is generally preceded by some form of vascular disease, such as Raynaud’s disease.
Primarily, the investigators are interested in “discriminating metabolic profiles depending on the characteristics of vascular disease, allowing early diagnosis of SSc at the onset of vascular lesions,” according to the registered study. Both newly diagnosed SSc patients, with a clinical diagnosis less than three years previous to enrollment, and established SSc patients, with a diagnosis of more than three years before enrollment, are vital to the analysis, and investigators will compare the two groups within one group of the study.
During the trial, an estimated 140 patients will be selected after fulfilling one of five inclusion criteria based on assigned groupings for the trial. Group 1 (SSc) must meet ACR/EULAR and/or Leroy and Medsger criteria for SSc; Group 2 (undifferentiated connective tissue disease, or UCDT) must meet Mosca et al. criteria; Group 3 (Raynaud) must exhibit primary and isolated Raynaud disease; Group 4 (vascular disease) must have type 2 diabetes, occlusive vascular disease, history of myocardial infarction, or a previous stroke; and Group 5 (healthy control) must show no signs of any aforementioned diseases.
All patients in all groups will have a skin biopsy, urine sample, and blood sample collected at a visit to one of three locations in France. Systemic sclerosis patients have the option of returning within three years for another test upon visceral complications. The researchers believe all samples will be collected, processed, and analyzed by October 2019. To make data collection and results analysis simpler, the researchers will compile information into a database that will be used to compare the five groups and identify correlations between the evolution of clinical and biological features of patients’ SSc.
Metabolomics is another member of the “omics” family of sciences, which also includes proteomics and genomics. It is the study of the metabolome, or the fingerprint of all chemical processes taking place within a cell. Understanding the reactions occurring within cells is vital to understanding why conditions such as SSc and SSc-related complications develop over time.