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Prevalence of Wild Type ATTR

Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03966105
Enrollment
94
Registered
2019-05-29
Start date
2019-11-01
Completion date
2022-10-31
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wild-type Transthyretin Amyloidosis

Keywords

wild-type TTR amyloidosis, lumbar spinal stenosis, prevalence

Brief 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.

Interventions

DIAGNOSTIC_TESTHE 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.

Sponsors

University of Kiel
CollaboratorOTHER
Ente Ospedaliero Cantonale, Bellinzona
CollaboratorOTHER
Oncology Institute of Southern Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Report the prevalence of ATTRwt in patients with CTS and/or LSS.2 yearsPrevalence of ATTRwt in a prospective population.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026