Prevalence of Wild Type ATTR

Sponsor

Oncology Institute of Southern Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT03966105

Collaborator

University of Kiel (Other), Ente Ospedaliero Cantonale, Bellinzona (Other)

300

Enrollment

Location

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with carpal tunnel syndrome (CTS) and/or lumbar spinal stenosis (LSS).

Condition or Disease	Intervention/Treatment	Phase
Transthyretin Amyloidosis	Diagnostic Test: HE and Congo red staining

Detailed Description

The study will include patients that receive surgical management and treatment for CTS and 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;

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis or Carpal Tunnel Syndrome

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients with CTS surgery indication	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.
Patients with LSS surgery indication	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.

Arm

Intervention/Treatment

Patients with CTS surgery indication

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.

Patients with LSS surgery indication

Diagnostic Test: HE and Congo red staining

Outcome Measures

Primary Outcome Measures

Report the prevalence of ATTRwt in patients with CTS and/or LSS. [2 years]
Prevalence of ATTRwt in a prospective population.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Carpal tunnel syndrome (CTS) documented at ENMG evaluation and/or o 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