OPLLNCT04963101
RNA-seq Analysis of PBMC in Patients With OPLL
An observational study of OPLL and PBMCs, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OPLL, PBMCs, Transcriptome
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Unable to sign the informed consent;
- Patients who do not meet the inclusion criteria or diagnostic criteria;
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Transcriptome Expression Profile of PBMCs in Patients With Ossification of the Posterior Longitudinal Ligament
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.
- Conditions
- OPLL, PBMCs, Transcriptome, Bioinformatics
What is being measured
The primary outcome is the main question the study is designed to answer.
circRNA, lncRNA, mRNA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start25 Jun 2021
- Primary completion25 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OPLLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huading Lu, Fifth Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963101
- Sponsor's protocol ID
- ZDWY.CSYGJWK.003
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Transcriptome Expression Profile of PBMCs in Patients With Ossification of the Posterior Longitudinal Ligament
- ClinicalTrials.gov ID
- NCT04963101
- Acronym / sponsor ID
- ZDWY.CSYGJWK.003
- Conditions
- OPLL, PBMCs, Transcriptome, Bioinformatics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Unable to sign the informed consent;
- Patients who do not meet the inclusion criteria or diagnostic criteria;
- <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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
circRNA, lncRNA, mRNA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
Related trials for OPLL
Active, not recruiting
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OPLL and PBMCs, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Jiang, M.D (+86 15653868023, jiangn57@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circRNA, lncRNA, mRNA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.