GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescence PCR Method)

NCT05668793 | Unknown DMC

• 1 other identifier: AD07
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.How consistent are the test results of the kit with the clinical reference diagnostic criteria?
2. 2.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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma diagnosis; methylation; GNB4; Riplet; Fluorescence PCR

Outcome Measures

Primary Outcomes (1)

• 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.

  immediately after the procedure

Secondary Outcomes (1)

• reliability

  immediately after the procedure

Study Arms (2)

Positive group

The positive group is composed of patients with hepatocellular carcinoma of different stages and pathological types.

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.).

Diagnostic Test: GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)

Interventions

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.

Negative group; Positive group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.).

You may not qualify if:

• 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；

Sponsors & Collaborators

• Wuhan Ammunition Life-tech Co., Ltd: lead
• Wuhan University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

1. Sample type: Human plasma samples. 2. Sample collection: Choose a blood collection vessel containing EDTA anticoagulant for blood collection, and gently turn it upside down after blood collection. Repeat 8-10 times and mix gently.The blood collection volume is not less than 10 mL. 3. Sample preservation:The collected blood samples should be centrifuged immediately to prepare plasma. If they cannot be processed in time, they should be stored at room temperature (15℃\~30℃) for no more than 3 hours, or at 2℃\~8℃ for no more than 8 hours, and whole blood should not be frozen. Plasma samples can be stored at 2℃\~8℃ for no more than 18 hours, at -25℃\~-15℃ for no more than 28 days, and at -80℃±5℃ for no more than 12 months.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Lanlan Dong, PhD

CONTACT

+86 1538088824; donglanlan.2006@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 30, 2022
• Study Start: January 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share