Screening for Systemic Amyloidosis Via the Ligamentum Flavum

NCT03923920 | Completed

• 1 other identifier: 18-1512
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloid; Amyloidosis; Spinal Stenosis; Transthyretin Amyloidosis; Primary Amyloidosis of Light Chain Type

Keywords

Biopsy; Surgery; Screening

Outcome Measures

Primary Outcomes (1)

• Incidence of amyloidosis in older patients undergoing spinal stenosis surgery

  Incidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery

  Baseline to 30 days

Study Arms (1)

Spinal Stenosis Biopsy

Biopsy of ligamentum flavum tissue during spinal stenosis surgery sent to pathology for amyloid-specific analysis

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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.

Spinal Stenosis Biopsy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing spinal stenosis surgery

You may qualify if:

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

You may not qualify if:

• History of congenital spinal stenosis or congenital spondyloarthropathy

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

• Sperry BW, Reyes BA, Ikram A, Donnelly JP, Phelan D, Jaber WA, Shapiro D, Evans PJ, Maschke S, Kilpatrick SE, Tan CD, Rodriguez ER, Monteiro C, Tang WHW, Kelly JW, Seitz WH Jr, Hanna M. Tenosynovial and Cardiac Amyloidosis in Patients Undergoing Carpal Tunnel Release. J Am Coll Cardiol. 2018 Oct 23;72(17):2040-2050. doi: 10.1016/j.jacc.2018.07.092.

  PMID: 30336828 BACKGROUND

• Yanagisawa A, Ueda M, Sueyoshi T, Okada T, Fujimoto T, Ogi Y, Kitagawa K, Tasaki M, Misumi Y, Oshima T, Jono H, Obayashi K, Hirakawa K, Uchida H, Westermark P, Ando Y, Mizuta H. Amyloid deposits derived from transthyretin in the ligamentum flavum as related to lumbar spinal canal stenosis. Mod Pathol. 2015 Feb;28(2):201-7. doi: 10.1038/modpathol.2014.102. Epub 2014 Sep 5.

  PMID: 25189643 BACKGROUND

• Westermark P, Westermark GT, Suhr OB, Berg S. Transthyretin-derived amyloidosis: probably a common cause of lumbar spinal stenosis. Ups J Med Sci. 2014 Aug;119(3):223-8. doi: 10.3109/03009734.2014.895786. Epub 2014 Mar 12.

  PMID: 24620715 BACKGROUND

• Sueyoshi T, Ueda M, Jono H, Irie H, Sei A, Ide J, Ando Y, Mizuta H. Wild-type transthyretin-derived amyloidosis in various ligaments and tendons. Hum Pathol. 2011 Sep;42(9):1259-64. doi: 10.1016/j.humpath.2010.11.017. Epub 2011 Feb 21.

  PMID: 21334722 BACKGROUND

• Sekijima Y, Yazaki M, Ueda M, Koike H, Yamada M, Ando Y. First nationwide survey on systemic wild-type ATTR amyloidosis in Japan. Amyloid. 2018 Mar;25(1):8-10. doi: 10.1080/13506129.2017.1409706. Epub 2017 Nov 28.

  PMID: 29182024 BACKGROUND

• M'bappe P, Grateau G. Osteo-articular manifestations of amyloidosis. Best Pract Res Clin Rheumatol. 2012 Aug;26(4):459-75. doi: 10.1016/j.berh.2012.07.003.

  PMID: 23040361 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Ligamentum flavum tissue (may contain surrounding tissue and subcutaneous fat)

MeSH Terms

Conditions

Alzheimer Disease; Amyloidosis; Spinal Stenosis; Amyloidosis, Hereditary, Transthyretin-Related; Immunoglobulin Light-chain Amyloidosis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mazen A Hanna, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: May 1, 2019
• Primary Completion: October 4, 2021
• Study Completion: December 2, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)