Gastric Cancer Marker Detection and Its Kit Development (GCMDKD)

August 11, 2021 updated by: Second Affiliated Hospital of Wenzhou Medical University
The gastric cancer diagnosis and treatment specifications clearly point out that tumor markers need to be detected in the process of diagnosis, efficacy evaluation and follow-up. However, there is currently a lack of gastric cancer markers with high sensitivity and specificity, and the detection of markers is limited to a single index analysis, which has many shortcomings such as long analysis time, large reagent consumption, and high detection cost. Therefore, this project will use protein chips to detect new types of gastric cancer patient markers and establish a multi-diagnostic model for early screening of gastric cancer. Finally, monoclonal antibodies will be produced against various high-specific tumor markers and a gastric cancer diagnostic kit will be established.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

1 Preliminary screening of early gastric cancer markers and antibody verification

(1) Recruitment and sample preparation of patients and healthy people: This project requires four batches of subjects, three batches of healthy people, early gastric cancer and advanced gastric cancer groups, with an average of 30 cases in each group. The other batch (the second batch) is healthy people and 30 cases of chronic atrophic gastritis, early gastric cancer and 30 cases of chronic atrophic gastritis. There were 100 cases in each of the advanced gastric cancer group, and 20 cases in each of liver cancer, colorectal cancer, and breast cancer. Serum and plasma samples obtained from subjects are used to screen potential gastric cancer tumor markers, verify the practicability of established gastric cancer tumor marker diagnostic models and test kits.

  1. Recruitment of gastric cancer patients: 30 cases of early gastric cancer patients (T1, T2) and advanced gastric cancer patients (T3, T4) are selected respectively. The staging of gastric cancer is based on the eighth edition of UICC (International Union Against Cancer) TNM staging. Subjects were screened according to the requirements of the informed consent form.
  2. Recruitment of healthy people: 30 volunteers without underlying diseases are selected as healthy control group. Subjects were screened according to the requirements of the informed consent form.
  3. Sample preparation: intravenous collection to obtain whole blood samples of patients and healthy controls. The sample requirement for each subject is 600ul of serum and plasma.

(2) Antibody chip screening for potential tumor markers of gastric cancer for the first time In order to screen for potential protein markers of gastric cancer, Raybiotech's high-throughput quantitative antibody chip (AAH-BLG-2000) was used to measure 640 in the first batch of subjects (early gastric cancer, advanced gastric cancer, and healthy controls each 30). Kind of human protein. Preliminarily screen out differential proteins, conduct bioinformatics analysis, and finally screen differentially expressed proteins relevant to the research.

2Customized antibody chip to verify gastric cancer tumor markers In order to further verify the candidate tumor markers for the diagnosis of gastric cancer, the differential proteins screened in the previous stage were customized for antibody chips. Use subject serum samples (second batch) for potential biomarker verification. According to the test results, the poorly specific proteins are discarded, and the more specific proteins are retained.

3. Establishment of diagnostic model Use regression analysis to combine and compare multiple differential proteins, perform quantitative analysis, establish a standard curve, establish a diagnostic model for highly specific differential proteins, and further measure the practicability of the highly specific differential protein diagnostic model.

4 Kit development Monoclonal antibodies were produced as capture antibodies for various high-specific tumor markers, and finally a gastric cancer diagnosis kit was established and promoted in clinical practice.

Establishment and performance measurement of gastric cancer diagnostic kit.

  1. Establish gastric cancer diagnostic kits, quality control reference materials and formulate relevant standards on the basis of the above research results.
  2. Precision testing: Dilute the self-made quality control reference materials to 3 concentrations of high, medium, and low, each with 3 replicate holes, repeat the test 10 times, and calculate the mean, standard deviation, and test value of each quality control reference product. Coefficient of Variation (CV) value.
  3. Sensitivity detection: Take the zero reference standard (specific difference protein) as the sample, and substitute the average value of the fluorescence value measured 20 times plus 2 times the standard deviation into the standard curve equation to calculate the minimum detection volume.
  4. Stability test: Divide the self-made kits into two groups and place them in a 4℃ freezer for 6 months and 37℃ for 7 days. The physical appearance of the kit, the linearity of the dose-response curve, accuracy, sensitivity, and minimum detection volume And other indicators are measured, and the specific detection method is the same as the above steps (2) and (3).
  5. Comparison with other gastric cancer detection methods: use self-prepared detection kits to detect 30 cases of early gastric cancer serum samples, 30 cases of advanced gastric cancer serum samples, and 30 healthy human serum samples, and analyze the test results.
  6. Promotion and optimization of the kit. Random sampling is performed among patients using this kit to observe the diagnosis rate of early clinical gastric cancer and the corresponding prognosis, and analyze the results of the return visit. According to the results of the return visit, continue to conduct corresponding experiments to optimize the performance of the kit, for example: improve its accuracy, sensitivity, and so on.

Study Type

Observational

Enrollment (Anticipated)

530

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 Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • No. 109, Xueyuan West Road, Lucheng District, Wenzhou City，Zhejiang provincece
        • Contact:

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from the Second Affiliated Hospital of Wenzhou Medical University, Yuying Children's Hospital, the First Affiliated Hospital of Wenzhou Medical University, and Taizhou Hospital, Zhejiang Province

Description

Inclusion Criteria:

patient

  1. Age is greater than or equal to 18 years old (including 18 years old);
  2. Patients who are diagnosed with cancer after pathological diagnosis;
  3. Can provide enough tissue samples;
  4. Have not received anti-tumor treatment in the past;
  5. Comply with the principle of informed consent and sign the informed consent form.

healthy person:

  1. Age is greater than or equal to 18 years old (including 18 years old);
  2. No underlying disease;
  3. Can provide enough tissue samples;
  4. Comply with the principle of informed consent and sign the informed consent form.

Exclusion Criteria:

  1. The tumor foci cannot be clearly derived from a specific tumor type;
  2. Those who have a history of other tumors, autoimmune diseases and allergies;
  3. Previously received anti-tumor treatments such as surgery, chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biological therapy or Chinese medicines with anti-cancer and anti-tumor effects in the instructions;
  4. Participated in any clinical trial within 90 days before the experiment;
  5. Received major surgery within 90 days before the experiment;
  6. Received bone marrow transplantation 90 days before the experiment;
  7. Subjects who may not be able to complete the study due to other reasons or who are determined by the investigator to be unsuitable to participate in this study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with early gastric cancer
Other: Blood collection
The subject will be drawn a 5ml blood sample
Patients with advanced gastric cancer
Other: Blood collection
The subject will be drawn a 5ml blood sample
healthy person
Other: Blood collection
The subject will be drawn a 5ml blood sample
Patients with colorectal cancer
Other: Blood collection
The subject will be drawn a 5ml blood sample
Liver cancer patients
Other: Blood collection
The subject will be drawn a 5ml blood sample
Breast cancer patient
Other: Blood collection
The subject will be drawn a 5ml blood sample
Patients with atrophic gastritis
Other: Blood collection
The subject will be drawn a 5ml blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Getting serum
Time Frame: 2023-12-30
Obtain subject serum
2023-12-30

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Collaborators

First Affiliated Hospital of Wenzhou Medical University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

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 (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2030

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2021-02-404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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