Study of Long Non-coding RNA SNHG15 as a Novel Biomarker in HBV Associated HCC

April 21, 2023 updated by: ChunqingWang, Qianfoshan Hospital

The First Affliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

In this study, the investigators will detect the expression of HBV-related HCC biomarker lncRNA SNHG15 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Paired hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and adjacent liver tissues were selected, and lncRNA SNHG15 was detected by RT-PCR. At the same time, healthy subjects were selected as the control group, and lncRNA SNHG15 in blood was detected by RT-PCR. At the same time, the correlation between lncRNA SNHG15 and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

No local or systemic treatment was performed before surgery. The patients were finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete.

Description

Inclusion Criteria:

  • The age and sex of the healthy control group were matched with that of HBV-associated patient group. There was no tumor in the other parts of the body, and no tumor in the blood system. The healthy control group did not have any liver benign diseases. There are no inflammatory diseases in other parts of the body; the functions of the liver, kidney, and heart were normal.

Exclusion Criteria:

  • The volunteer has tumors in the liver or other parts of the body, or blood system tumors; The volunteer has benign liver diseases; The patient has inflammatory disease elsewhere. If the volunteer has any one of the above diseases, it shall be excluded.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HBV-associated HCC group
The age and gender of patients are not limited. The patient was finally diagnosed as HBV-associated HCC by imaging examination and pathology.
Diagnostic test: No intervention was required for patients or control group in this study
The patient was treated normally and no intervention was required in this study
negative control group
The age and sex of this group were matched with that of HBV-associated HCC patient group. The patient did not have any tumor but had HBV infection. The functions of the renal and heart were normal.
Diagnostic test: No intervention was required for patients or control group in this study
The patient was treated normally and no intervention was required in this study
Healthy control group
The age and sex of the healthy control group were matched with that of HBV-associated HCC patient group. There was no tumor in the liver or other parts of the body, and no tumor in the blood system. The healthy control group did not have any liver benign diseases. There are no inflammatory diseases in other parts of the body. The functions of the liver, kidney, and heart were normal.
Diagnostic test: No intervention was required for patients or control group in this study
The patient was treated normally and no intervention was required in this study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Detection of lncRNA SNHG15 in HBV-associated HCC patients before surgery
Time Frame: 1 to 3 days before surgery
The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.
1 to 3 days before surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Detection of lncRNA SNHG15 in HBV-associated HCC patients 1 week after surgery
Time Frame: one week after surgery
  1. The expressions of lncRNA SNHG15 in tissues: In the tumor and adjacent tissues from HBV-associated HCC patients, the expressions of lncRNA SNHG15were measured by real-time fluorescence quantitative PCR method.
  2. The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.
one week after surgery
Detection of lncRNA SNHG15 in HBV-associated HCC patients at 6 months after surgery
Time Frame: 6 months postoperatively
The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.
6 months postoperatively
Detection of lncRNA SNHG15 in the control groups as baseline
Time Frame: the level of lncRNA SNHG15 were detected as baseline
The expression of lncRNA SNHG15 in blood samples: The expressions of lncRNA SNHG15 in blood samples were detected by real-time fluorescence quantitative PCR method.
the level of lncRNA SNHG15 were detected as baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qianfoshan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ChunqingWang [chunqingwang], Dr, Qianfoshan Hospital

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.

General Publications

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YXLL-KY-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data (IPD) until the project is completed. Sharing IPD may be available 1 year after publication.

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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