Gastric Cancer Marker Detection and Its Kit Development

NCT05010863 | Recruiting

• 1 other identifier: SAHoWMU-CR2021-02-404
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Getting serum

  Obtain subject serum

  2023-12-30

Study Arms (7)

Patients with early gastric cancer

Other: Blood collection

Patients with advanced gastric cancer

Other: Blood collection

healthy person

Other: Blood collection

Patients with colorectal cancer

Other: Blood collection

Liver cancer patients

Other: Blood collection

Breast cancer patient

Other: Blood collection

Patients with atrophic gastritis

Other: Blood collection

Interventions

Blood collection OTHER

The subject will be drawn a 5ml blood sample

Breast cancer patient; Liver cancer patients; Patients with advanced gastric cancer; Patients with atrophic gastritis; Patients with colorectal cancer; Patients with early gastric cancer; healthy person

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patient
• Age is greater than or equal to 18 years old (including 18 years old);
• Patients who are diagnosed with cancer after pathological diagnosis;
• Can provide enough tissue samples;
• Have not received anti-tumor treatment in the past;
• Comply with the principle of informed consent and sign the informed consent form.
• healthy person:
• Age is greater than or equal to 18 years old (including 18 years old);
• No underlying disease;
• Can provide enough tissue samples;
• Comply with the principle of informed consent and sign the informed consent form.

You may not qualify if:

• The tumor foci cannot be clearly derived from a specific tumor type;
• Those who have a history of other tumors, autoimmune diseases and allergies;
• 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;
• Participated in any clinical trial within 90 days before the experiment;
• Received major surgery within 90 days before the experiment;
• Received bone marrow transplantation 90 days before the experiment;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

No. 109, Xueyuan West Road, Lucheng District, Wenzhou City，Zhejiang provincece

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Weijian Sun, PhD

CONTACT

13857772361; fame198288@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: January 1, 2021
• Primary Completion: December 30, 2023
• Study Completion (Estimated): December 30, 2030
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)