NCT04963101

Brief Summary

In this study, we planned to identify transcriptome expression profiles (circRNAs, lncRNAs, and mRNAs) from peripheral blood mononuclear cells (PBMCs) of 30 patients with OPLL and 30 other non-OPLL patients by high-throughput sequencing.Sequence analysis was used to predict miRNAs that might bind circRNAs and lncRNAs.Through bioinformatics analysis, competitive endogenous RNAs (cerRNAs), as well as coexpression networks among circRNAs, lncRNAs, miRNAs, and mRNAs, were constructed to provide key molecules and signaling pathways associated with OPLL.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 25, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 2, 2021

Last Update Submit

July 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • circRNA, lncRNA, mRNA

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 30 peripheral blood samples were enrolled in this study, including 15 cases in the OPLL disease group and 15 cases in the non-OPLL control group.

You may qualify if:

  • Voluntarily participate in the clinical study and sign the informed consent;
  • All OPLL patients meet the diagnostic criteria set out in the JOA Clinical Practice Guidelines for Spinal Ligament Osification 2019;
  • Age ≥18, gender unlimited;
  • All non-OPLL patients and healthy volunteers have no serious diseases of the heart, lung, brain, liver, kidney and blood system, such as autoimmune diseases, tumors, psychosis, infectious diseases, etc., and have no bad habits or recent history of taking special drugs.

You may not qualify if:

  • Unable to sign the informed consent;
  • \<18 years old;
  • Women planning to become pregnant/lactating/pregnant;
  • Complicated with serious heart, lung, brain, liver, kidney, blood system diseases, such as autoimmune diseases, tumors, mental illness, infectious diseases, drug addiction and other bad addicts;Those who have recently taken special drugs;
  • Individuals who do not agree to donate peripheral blood or who are obviously uncomfortable with drawing blood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facility

Zhuhai, Guangdong, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of orthopaedics

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 15, 2021

Study Start

June 25, 2021

Primary Completion

June 25, 2022

Study Completion

June 30, 2022

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations