NCT03492372

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Mar 2015Jul 2026

Study Start

First participant enrolled

March 31, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

11.3 years

First QC Date

January 25, 2018

Last Update Submit

September 15, 2025

Conditions

Spinal Diseases

Outcome Measures

Primary Outcomes (1)

  • RNA expression

    Measure RNA levels in spinal tissues samples (ng/mL)

    Baseline

Study Arms (1)

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.

Interventions

Waste tissues are collected at the time of spinal surgery.OTHER

This is a single visit study. Waste tissues are collected at the time of spinal surgery.

Spine patients

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Surgeries where spinal tissues are not being removed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Spinal tissues removed as discarded tissue, waste, or surgical debris. Examples: disc, cartilage, ligament

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • A.Noelle Larson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2018

First Posted

April 10, 2018

Study Start

March 31, 2015

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)