NCT03966105

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

May 24, 2019

Last Update Submit

March 23, 2023

Conditions

Wild-type Transthyretin Amyloidosis

Keywords

wild-type TTR amyloidosislumbar spinal stenosisprevalence

Outcome Measures

Primary Outcomes (1)

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

    Prevalence of ATTRwt in a prospective population.

    2 years

Study Arms (1)

Patients with LSS surgery indication

Diagnostic Test: HE and Congo red staining

Interventions

HE and Congo red stainingDIAGNOSTIC_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.

Patients with LSS surgery indication

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective population of 100 patients undergoing LSS surgery.

You may qualify if:

  • 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

You may not qualify if:

  • Previous diagnosis of amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Institute of Southern Switzerland

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopsies

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Adalgisa Condoluci, MD

    Oncology Institute of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Resident Physician

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

November 1, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

CH(1)