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Completed

NCT Number: NCT03966105

Prevalence of Wild Type ATTR

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncology Institute of Southern Switzerland

Bellinzona, Canton Ticino, 6500, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI
  • Availability of the baseline and follow-up annotations
  • Informed consent will be obtained from the patient before any study related procedures

Exclusion criteria

  • Previous diagnosis of amyloidosis

Treatment and study plan

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.

Primary outcomes

  1. Report the prevalence of ATTRwt in patients with CTS and/or LSS.

    Time frame: 2 years

    Prevalence of ATTRwt in a prospective population.

Sponsors and collaborators

Lead sponsor

Oncology Institute of Southern Switzerland

Other

Collaborators

  • Ente Ospedaliero Cantonale, Bellinzona
  • University of Kiel

Registry information

Official study title

Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 29, 2019
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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