Clinical trial · Observational
Screening for Systemic Amyloidosis Via the Ligamentum Flavum
NCT03923920CI-TRIAL-00055646ALFcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amyloid | — | UNRESOLVED | — |
| Amyloidosis | Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Primary Amyloidosis of Light Chain Type | — | UNRESOLVED | — |
| Spinal Stenosis | — | UNRESOLVED | — |
| Transthyretin Amyloidosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Spinal Stenosis Biopsy
- description
- Biopsy of ligamentum flavum tissue during spinal stenosis surgery sent to pathology for amyloid-specific analysis
- interventionNames
- Procedure: Biopsy
Primary outcomes (1)
- measure
- Incidence of amyloidosis in older patients undergoing spinal stenosis surgery
- timeFrame
- Baseline to 30 days
- description
- Incidence of amyloid deposits in removed ligamentum flavum tissue of older patients undergoing spinal stenosis surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDSperry 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
- BACKGROUNDYanagisawa 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
- BACKGROUNDWestermark 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
- BACKGROUNDSueyoshi 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
- BACKGROUNDSekijima 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
- BACKGROUNDM'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