An observational study in Wild-type Transthyretin Amyloidosis, sponsored by Oncology Institute of Southern Switzerland. Completed at 1 site in Switzerland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Oncology Institute of Southern Switzerland · Observational
Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).
The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.
491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.
This study's enrollment of 94 is below the median of 141 across 156 observational studies indexed under Amyloidosis.
Browse Amyloidosis studies →Oncology Institute of Southern Switzerland is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Prospective population of 100 patients undergoing LSS surgery.
Exclusion Criteria:
Diagnostic Test: HE and Congo red staining
Biopsies will be formalin fixed, processed routinely, and sent to the Department of Pathology for evaluation by hematoxylin and eosin and Congo red staining by pathologists. Biopsy specimens with confirmed amyloid deposits via Congo red staining will be further analyzed using immunohistochemistry for subtyping.
Report the prevalence of ATTRwt in patients with CTS and/or LSS.
Prevalence of ATTRwt in a prospective population.
Time frame: 2 years
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Oncology Institute of Southern Switzerland