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出境医 / 临床实验 / Screening for Systemic Amyloidosis Via the Ligamentum Flavum (ALF)
Screening for Systemic Amyloidosis Via the Ligamentum Flavum (ALF)
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.
| 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.
Study Design
| 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, 2022 |
| Estimated Study Completion Date : | October 1, 2022 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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)
Eligibility Criteria
| 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
Criteria
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
Contacts and Locations
Contacts
| Contact: Mazen A Hanna, MD | 2164443490 | Hannam@ccf.org | |
| Contact: Joseph P Donnelly, MD | 3028932315 | donnelj@ccf.org |
Locations
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Mazen Hanna, M. D. 216-444-3490 hannam@ccf.org | |
Sponsors and Collaborators
The Cleveland Clinic
Investigators
| Principal Investigator: | Mazen A Hanna, MD | The Cleveland Clinic |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 18, 2019 | ||||||||
| First Posted Date | April 23, 2019 | ||||||||
| Last Update Posted Date | May 19, 2021 | ||||||||
| Actual Study Start Date | May 1, 2019 | ||||||||
| Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Screening for Systemic Amyloidosis Via the Ligamentum Flavum | ||||||||
| Official Title | Screening for Systemic Amyloidosis Via the Ligamentum Flavum | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Ligamentum flavum tissue (may contain surrounding tissue and subcutaneous fat)
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients undergoing spinal stenosis surgery | ||||||||
| Condition |
|
||||||||
| Intervention | 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.
|
||||||||
| Study Groups/Cohorts | Spinal Stenosis Biopsy
Biopsy of ligamentum flavum tissue during spinal stenosis surgery sent to pathology for amyloid-specific analysis
Intervention: Procedure: Biopsy
|
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | October 1, 2022 | ||||||||
| Estimated Primary Completion Date | April 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 50 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03923920 | ||||||||
| Other Study ID Numbers | 18-1512 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mazen Hanna MD, The Cleveland Clinic | ||||||||
| Study Sponsor | The Cleveland Clinic | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | The Cleveland Clinic | ||||||||
| Verification Date | April 2021 | ||||||||
