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Spots Global Cancer Trial Database for Screening for Systemic Amyloidosis Via the Ligamentum Flavum

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Screening for Systemic Amyloidosis Via the Ligamentum Flavum

Official Title: Screening for Systemic Amyloidosis Via the Ligamentum Flavum

Study ID: NCT03923920

Interventions

Biopsy

Study Description

Brief Summary: The investigators will prospectively evaluate for the presence of amyloid deposits in ligamentum flavum (yellow ligament) tissue samples obtained from patients undergoing spinal stenosis surgery. Patients who have tissue that stains positive for amyloid will be referred to an amyloidosis specialist.

Detailed Description: Similar to carpal tunnel syndrome, spinal stenosis is associated with systemic amyloidosis and presents earlier than cardiac amyloidosis symptoms - 21-45% of ATTR patients and case reports in AL patients. The investigators' recent study found that 10% of older patients undergoing carpal tunnel release surgery were positive for amyloidosis, with 20% of that group presenting with cardiac involvement. 70% of the amyloid-positive group had a history of spinal stenosis and 40% required surgical intervention. Surgical intervention for spinal stenosis could provide an opportunity to screen for amyloidosis through yellow ligament (ligamentum flavum) biopsy. This study will look at the prevalence of amyloidosis in patients undergoing surgical intervention for non-congenital spinal stenosis and spondyloarthropathy. The investigators hypothesize that 10% of such patients will be positive for amyloidosis.

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cleveland Clinic, Cleveland, Ohio, United States

Contact Details

Name: Mazen A Hanna, MD

Affiliation: The Cleveland Clinic

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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