Molecular Characterization of Spinal Tissue

August 7, 2023 updated by: A. Noelle Larson, Mayo Clinic
The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Discarded surgical material from spinal procedures is collected. RNA analysis and other tests on the tissue is performed to determine markers of pathologic disease and to develop pharmacologic treatment strategies for pediatric spinal disorders.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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.

Eligibility Criteria

Ages Eligible for Study

1 year to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing spinal surgery where spinal tissues (disc, cartilage, ligament, etc.) is removed as discarded tissue, waste, or surgical debris.

Description

Inclusion Criteria:

  • Children and adults undergoing surgical procedures where spinal tissues are removed as a normal part of their procedure. Material from adults may be collected as a control group.

Exclusion Criteria:

  • Surgeries where spinal tissues are not being removed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spine patients
Patients undergoing spine surgery where spinal tissue is discarded/removed will be recruited. Tissue samples will be used to look at normal and pathologic molecular signatures.
Other: Waste tissues are collected at the time of spinal surgery.
This is a single visit study. Waste tissues are collected at the time of spinal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNA expression
Time Frame: Baseline
Measure RNA levels in spinal tissues samples (ng/mL)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: A.Noelle Larson, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

March 31, 2015

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-008177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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