Actively Recruiting

Age: 18Years - 100Years
All Genders
Healthy Volunteers
NCT05991947

Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer

Led by Zhejiang Cancer Hospital · Updated on 2024-09-05

1100

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. A new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated. Specifically, the study will involve the following subjects and quantities: 700 participants from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.

CONDITIONS

Official Title

Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 100 years
  • ECOG performance status of 0 or 1
  • Pathologically confirmed Stage I-III gastric cancer patients
  • No prior anti-tumor treatment before blood collection, including chemotherapy, radiotherapy, targeted therapy, surgery, or anesthesia
  • Ability to understand the study and provide written informed consent along with family support
Not Eligible

You will not qualify if you...

  • Other hereditary diseases or tumors
  • Severe inflammatory reactions from acute illnesses within 14 days before blood draw or steroid use
  • Previous organ, stem cell, or bone marrow transplantation, or blood transfusion within one month before enrollment
  • Pregnant women
  • Participation in other clinical trials involving medication within 60 days, including anesthesia
  • Severe cardiovascular diseases, uncontrolled infections, or other uncontrollable comorbidities
  • Inability of participant or family to understand study conditions and objectives

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

X

Xiangdong Cheng, Professor

CONTACT

L

Li Yuan, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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