Oncology Institute of Southern Switzerland
Bellinzona, Canton Ticino, 6500, Switzerland
NCT Number: NCT03966105
Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).
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Notify Me50 year and older
All sexes
Observational
Bellinzona, Canton Ticino, 6500, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 years
Prevalence of ATTRwt in a prospective population.
Oncology Institute of Southern Switzerland
Other
Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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