Hepatocellular CarcinomaNCT05668793
GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescence PCR Method)
An observational study of Hepatocellular Carcinoma, run by Wuhan Ammunition Life-tech Co., Ltd.
Trial summary
The goal of this observational study is to test the clinical efficacy of "GNB4 and Riplet gene methylation combined detection kit (fluorescence PCR method)"in hepatocellular carcinoma auxiliary diagnosis. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2023
- How long will I take part?
- 1 Month
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 1. The number of patients with hepatocellular carcinoma should be not less than 350, and should cover different stages and different pathological types. 2. The number of patients with other malignancies of the digestive system should not be less than 200. 3. The number of patients with benign liver disease should not be less than 300. 4. The number of all samples enrolled should be not less than 1000 cases.
Who may be able to join
- Those who meet any of the following conditions can be enrolled into the hepatocellular carcinoma group：
- Patients who have suspected placeholder lesions in the liver area after existing examinations and plan to undergo multi-parameter MRI, CT dynamic enhancement scans, ultrasound imaging or enhanced magnetic resonance scans with the hepatocyte-specific contrast agent disodium gadolinium cerate (Gd-EOB-DTPA)；
- Patients who are highly suspected of liver cancer diagnosed by multi-parameter MRI, CT dynamic enhancement scan, ultrasound contrast, liver cell-specific contrast agent disodium gadolinium cerate (Gd-EOB-DTPA) enhanced magnetic resonance scan or puncture biopsy, before treatment and surgery；
- Those who meet any of the following conditions can be enrolled into the negative group：
- Patients with benign liver diseases (including cirrhosis, hepatitis, fatty liver, liver adenoma, liver cyst, etc.).
- Untreated patients with other digestive system tumors (including stomach cancer, colorectal cancer, esophageal cancer, pancreatic cancer, gallbladder/duct cancer, etc.) and patients with non-digestive system tumors (including lung cancer, thyroid cancer, cervical cancer, endometrial cancer, breast cancer, prostate cancer, urothelial cancer, etc.).
Who cannot join
- Those who meet any of the following conditions should be excluded：
- Patients with hepatocellular carcinoma who have received anti-tumor treatments such as radiotherapy/chemotherapy；
- Hepatocellular carcinoma patients suffering from other malignant tumors at the same time；
- Samples that are not kept as required or samples of hemolysis；
- The sample size collected does not meet the testing requirements；
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Hepatocellular Carcinoma: a Clinical Trial
The goal of this observational study is to test the clinical efficacy of "GNB4 and Riplet gene methylation combined detection kit (fluorescence PCR method)"in hepatocellular carcinoma auxiliary diagnosis. The main questions it aims to answer are:
- How consistent are the test results of the kit with the clinical reference diagnostic criteria?
- Sanger sequencing can visually show whether each sample contains methylation sites, so in this clinical trial, the kit results were compared with Sanger sequencing results to analyze the reagent's accuracy in detecting GNB4 and Riplet gene methylation.
Each participant is required to provide no less than 10 ml of blood to complete the kit test.
Read the detailed description
- Before the start of clinical trials, investigators will be uniformly trained by experts from the clinical trial institutions or from the sponsor. Researchers should be familiar with and correctly operated the test kits and instruments.
- Throughout the clinical trial process, the clinical trial institution should ensure that it follows the scheduled protocal and strictly abide by the instructions of instruments and reagents.
- The entire trial process should be completed by the researchers in the laboratory of the clinical trial institution. Except for the necessary guidance, the technical staff of the sponsor shall not interfere with the experimental process at will, especially data collection process. Blind methods should be used to ensure the objectivity of the test results.
- The sponsor shall ensure that the test reagents are qualified, and transported to the clinical institution in accordance with the transportation conditions in the manual. Researchers should record the information of receipt, storage, use, handling and recycling process.
- Researchers should ensure that the clinical trial data are recorded accurately, completely, clearly and in a timely manner. Any changes to the data should be signed and dated by the researcher, and the original records should be kept. The original records should be clear and recognizable. All observations and findings in clinical trials should be truthfully recorded and verified to ensure the reliability of the data and to ensure that the conclusions of clinical trials are derived from the original records.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
- Keywords
- Hepatocellular Carcinoma diagnosis, methylation, GNB4, Riplet, Fluorescence PCR
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)Diagnostic test
Blood samples from participants in the group were collected and methylation tests were performed according to the kit instructions.
| Study group | Role | What they receive |
|---|---|---|
| Positive group | The positive group is composed of patients with hepatocellular carcinoma of different stages and pathological types. Receives: Diagnostic Test: GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method) | |
| Negative group | 1. Patients with other digestive system malignancies (including stomach cancer, esophageal cancer, colorectal cancer, pancreatic cancer, gallbladder/duct cancer, etc.), patients with non-digestive system malignancies (including lung cancer, thyroid cancer, cervical cancer, endometrial cancer, breast cancer, prostate cancer, urothelial cancer, etc.).
2. Patients with benign liver diseases (such as cirrhosis, hepatitis, fatty liver, liver adenoma, liver cyst, etc.). Receives: Diagnostic Test: GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity
In this study, validity indicates the consistency of methylation test with the clinical reference diagnostic standards, including sensitivity and specificity. Sensitivity indicates the proportion of methylation-positive samples in hepatocellular carcinoma samples. Specificity indicates the proportion of methylation-negative samples in nagative group.
Measured: immediately after the procedure
Secondary outcomes (1)
reliability
In this study, the reliability evaluation included two indicators, namely the agreement rate of methylation detection with Sanger sequencing, and the Kappa value of the two methods.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 1,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Wuhan Ammunition Life-tech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wuhan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668793
- Sponsor's protocol ID
- AD07
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential information of the individual participant will be retained by investigators and clinical trial institutions, any personal information of subjects will not be disclosed in reports, publications, etc. Direct access to source data and and files is only allowed for the purpose of monitoring, auditing or inspection, without revealing the subject's privacy. The medical products administration may inspect the basic documents of clinical trials of medical devices in order to confirm the authenticity and the integrity of the collected data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Hepatocellular Carcinoma: a Clinical Trial
- ClinicalTrials.gov ID
- NCT05668793
- Acronym / sponsor ID
- AD07
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma diagnosis, methylation, GNB4, Riplet, Fluorescence PCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wuhan Ammunition Life-tech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Wuhan University
- Study start
- Jan 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Dec 2022 (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.
The goal of this observational study is to test the clinical efficacy of "GNB4 and Riplet gene methylation combined detection kit (fluorescence PCR method)"in hepatocellular carcinoma auxiliary diagnosis. The main questions it aims to answer are:
- How consistent are the test results of the kit with the clinical reference diagnostic criteria?
- Sanger sequencing can visually show whether each sample contains methylation sites, so in this clinical trial, the kit results were compared with Sanger sequencing results to analyze the reagent's accuracy in detecting GNB4 and Riplet gene methylation.
Each participant is required to provide no less than 10 ml of blood to complete the kit test.
Detailed description
- Before the start of clinical trials, investigators will be uniformly trained by experts from the clinical trial institutions or from the sponsor. Researchers should be familiar with and correctly operated the test kits and instruments.
- Throughout the clinical trial process, the clinical trial institution should ensure that it follows the scheduled protocal and strictly abide by the instructions of instruments and reagents.
- The entire trial process should be completed by the researchers in the laboratory of the clinical trial institution. Except for the necessary guidance, the technical staff of the sponsor shall not interfere with the experimental process at will, especially data collection process. Blind methods should be used to ensure the objectivity of the test results.
- The sponsor shall ensure that the test reagents are qualified, and transported to the clinical institution in accordance with the transportation conditions in the manual. Researchers should record the information of receipt, storage, use, handling and recycling process.
- Researchers should ensure that the clinical trial data are recorded accurately, completely, clearly and in a timely manner. Any changes to the data should be signed and dated by the researcher, and the original records should be kept. The original records should be clear and recognizable. All observations and findings in clinical trials should be truthfully recorded and verified to ensure the reliability of the data and to ensure that the conclusions of clinical trials are derived from the original records.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive group | – | Diagnostic Test: GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)The positive group is composed of patients with hepatocellular carcinoma of different stages and pathological types. |
| Negative group | – | Diagnostic Test: GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)1. Patients with other digestive system malignancies (including stomach cancer, esophageal cancer, colorectal cancer, pancreatic cancer, gallbladder/duct cancer, etc.), patients with non-digestive system malignancies (including lung cancer, thyroid cancer, cervical cancer, endometrial cancer, breast cancer, prostate cancer, urothelial cancer, etc.). 2. Patients with benign liver diseases (such as cirrhosis, hepatitis, fatty liver, liver adenoma, liver cyst, etc.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. The number of patients with hepatocellular carcinoma should be not less than 350, and should cover different stages and different pathological types. 2. The number of patients with other malignancies of the digestive system should not be less than 200. 3. The number of patients with benign liver disease should not be less than 300. 4. The number of all samples enrolled should be not less than 1000 cases.
Key inclusion criteria (6 listed)
- Those who meet any of the following conditions can be enrolled into the hepatocellular carcinoma group：
- Those who meet any of the following conditions can be enrolled into the negative group：
Key exclusion criteria (5 listed)
- Those who meet any of the following conditions should be excluded：
- Patients with hepatocellular carcinoma who have received anti-tumor treatments such as radiotherapy/chemotherapy；
- Hepatocellular carcinoma patients suffering from other malignant tumors at the same time；
- Samples that are not kept as required or samples of hemolysis；
- The sample size collected does not meet the testing requirements；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)Blood samples from participants in the group were collected and methylation tests were performed according to the kit instructions. | Diagnostic test | Negative group, Positive group |
Primary outcome
validity
Time frame: immediately after the procedure
In this study, validity indicates the consistency of methylation test with the clinical reference diagnostic standards, including sensitivity and specificity. Sensitivity indicates the proportion of methylation-positive samples in hepatocellular carcinoma samples. Specificity indicates the proportion of methylation-negative samples in nagative group.
1 secondary outcome
reliability
Time frame: immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Individual participant dataSharing planned: No. Confidential information of the individual participant will be retained by investigators and clinical trial institutions, any personal information of subjects will not be disclosed in reports, publications, etc. Direct access to source data and and files is only allowed for the purpose of monitoring, auditing or inspection, without revealing the subject's privacy. The medical products administration may inspect the basic documents of clinical trials of medical devices in order to confirm the authenticity and the integrity of the collected data.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Wuhan Ammunition Life-tech Co., Ltd.
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 6 inclusion and 5 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 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Lanlan Dong, PhD (+86 1538088824, donglanlan.2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity (time frame: immediately after the procedure). 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 30 Dec 2022.