NCT03966105

Prevalence of Wild Type ATTR

Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Oncology Institute of Southern Switzerland · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).

Detailed description

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.

Conditions

• Wild-type Transthyretin Amyloidosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-10-31
• Completion: 2022-10-31
• First posted: 2019-05-29
• Last updated: 2023-03-27

Locations

1 site across 1 country: Switzerland