Molecular Characterization of Spinal Tissue

Study Purpose

The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Year - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03492372
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

A.Noelle Larson, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spinal Diseases
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905