RECRUITING

Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective. The specific aims of this epidemiologic investigation include: 1. To identify subjects with previous lumbar spinal stenosis (LSS) Surgery who have evidence of transthyretin (TTR) amyloid deposits in spinal specimens and could be at risk for ATTR cardiac amyloidosis. 2. To evaluate for ATTR-CA among those with localized TTR in the spinal tissue. The study will also explore the following: 1. The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining. 2. The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry. 3. Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H\&E staining. 4. Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in subject's spine by myocardial uptake of technetium pyrophosphate scan (Tc99-PYP).

Official Title

Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis

Quick Facts

Study Start:2023-09-19
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06034405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Clinically indicated spinal decompressive surgery within 20 years prior to enrollment.
  2. 2. Age ≥50 years at the time of the surgery.
  3. 3. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
  1. 1. Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).
  2. 2. Known TTR amyloidosis.
  3. 3. Other reason that would make the subject inappropriate for entry into this study.

Contacts and Locations

Study Contact

Mathew S Maurer, MD
CONTACT
212-932-4537
msm10@cumc.columbia.edu
Samantha L Guadalupe, MHA
CONTACT
212-932-4537
slg2172@cumc.columbia.edu

Principal Investigator

Mathew S Maurer, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Cedars-Sinai Medical Center
Beverly Hills, California, 90211
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Boston Medical Center
Boston, Massachusetts, 02359
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Mathew S Maurer, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19
Study Completion Date2028-05

Study Record Updates

Study Start Date2023-09-19
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • Lumbar Spinal Stenosis
  • Cardiac Amyloidosis
  • ATTR Amyloidosis Wild Type
  • ATTR Gene Mutation
  • ATTRV122I Amyloidosis
  • Cardiomyopathy, Hypertrophic