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Screening for Systemic Amyloidosis Via the Ligamentum Flavum (ALF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03923920
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : April 30, 2020
Information provided by (Responsible Party):
Mazen Hanna MD, The Cleveland Clinic

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.

Condition or disease Intervention/treatment
Amyloid Amyloidosis Spinal Stenosis Transthyretin Amyloidosis Primary Amyloidosis of Light Chain Type Procedure: Biopsy

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Systemic Amyloidosis Via the Ligamentum Flavum
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : October 1, 2021

Group/Cohort Intervention/treatment
Spinal Stenosis Biopsy
Biopsy of ligamentum flavum tissue during spinal stenosis surgery sent to pathology for amyloid-specific analysis
Procedure: Biopsy
During clinically-scheduled spinal stenosis surgery, ligamentum flavum tissue (which may contain surrounding tissue and subcutaneous fat) that is removed during the procedure will be sent to pathology to be analyzed with amyloid-specific staining.

Primary Outcome Measures :
  1. Incidence of amyloidosis in older patients undergoing spinal stenosis surgery [ Time Frame: Baseline to 30 days ]
    Incidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery

Biospecimen Retention:   Samples With DNA
Ligamentum flavum tissue (may contain surrounding tissue and subcutaneous fat)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing spinal stenosis surgery

Inclusion Criteria:

  • Age ≥50 years
  • Undergoing surgical intervention for non-congenital spinal stenosis and/or spondyloarthropathy
  • Able to consent

Exclusion Criteria:

  • History of congenital spinal stenosis or congenital spondyloarthropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03923920

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Contact: Mazen A Hanna, MD 2164443490
Contact: Joseph P Donnelly, MD 3028932315

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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Mazen Hanna, M. D.    216-444-3490   
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Mazen A Hanna, MD The Cleveland Clinic

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Responsible Party: Mazen Hanna MD, Principle Investigator, The Cleveland Clinic Identifier: NCT03923920    
Other Study ID Numbers: 18-1512
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mazen Hanna MD, The Cleveland Clinic:
Additional relevant MeSH terms:
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Immunoglobulin Light-chain Amyloidosis
Spinal Stenosis
Proteostasis Deficiencies
Metabolic Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases