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| Name | Class |
|---|---|
| University of Kiel | OTHER |
| Ente Ospedaliero Cantonale, Bellinzona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with LSS surgery indication |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HE and Congo red staining | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Report the prevalence of ATTRwt in patients with CTS and/or LSS. | Prevalence of ATTRwt in a prospective population. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Prospective population of 100 patients undergoing LSS surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Adalgisa Condoluci, MD | Oncology Institute of Southern Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Southern Switzerland | Bellinzona | Canton Ticino | 6500 | Switzerland |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Tissue biopsies
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