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

NCT05991947 | Recruiting

• 1 other identifier: IRB-2023-427
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer; Healthy

Keywords

Gastric Cancer; Proteomics; Diagnostic model

Outcome Measures

Primary Outcomes (1)

• Differences in ctDNA gene and tumor-specific proteins expression

  Collect 15ml of peripheral blood from subjects, extract ctDNA, and detect mutations in 18 genes (AKT1, APC, BRAF, CDKN2A, CTNNB1, EGFR, FBXW7, FGFR2, GNAS, HRAS, KRAS, NRAS, PIK3CA, PPP2R1A, PTEN, TP53, TOP2A, RNF43) and the expression levels of 9 tumor-specific proteins (CA-125, CA 19-9, CEA, HGF, IL-6, OPN, Prolactin, AFP, HE4) using the FireflyTM method based on amplicon library deep sequencing. Determine the performance indicators including sensitivity, specificity, and accuracy of the existing AccuScreen system and diagnostic model for early screening of gastric cancer. By conducting tests on 10 samples, explore the genomic fragments of gastric cancer, establish targets for ctDNA fragmentomics (fragment length, cleavage sites, end preferences, etc.), and analysis algorithms for gastric cancer fragmentomics, to further evaluate the feasibility of enhancing sensitivity and specificity for early gastric cancer screening through ctDNA fragmentomics detection.

  First day in hospital

Study Arms (2)

gastric cancer patients

Other: No intervention

healthy individuals

Other: No intervention

Interventions

No intervention OTHER

No intervention measures are needed.

gastric cancer patients; healthy individuals

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Number of Participants and Total Enrollment: Zhejiang Cancer Hospital: 700/700 (350 cases of gastric cancer patients, 350 cases of healthy individuals) Sichuan Cancer Hospital: 200/200 (100 cases of gastric cancer patients, 100 cases of healthy individuals) The Sixth Affiliated Hospital of Sun Yat-sen University: 200/200 (100 cases of gastric cancer patients, 100 cases of healthy individuals)

You may qualify if:

• Age between 18 and 100 years.
• ECOG performance status of 0 or 1.
• Pathologically confirmed Stage I-III gastric cancer patients.
• Patients who have not undergone any anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection.
• Subjects and their family members who can comprehend the research protocol and are willing to participate in the study, providing written informed consent.

You may not qualify if:

• Presence of other hereditary diseases or other tumors.
• Severe inflammatory reactions caused by acute illnesses within 14 days prior to blood draw or use of steroids.
• Previous organ transplantation, stem cell transplantation, bone marrow transplantation, or blood transfusion within the last month before enrollment.
• Pregnant women.
• Participation in other clinical trials requiring medication intake within the last 60 days (including anesthesia).
• Severe cardiovascular diseases, uncontrolled infections, or other uncontrollable comorbidities.
• Subjects or family members unable to comprehend the conditions and objectives of the study.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiangdong Cheng, Professor

CONTACT

+86-13968032995; chengxd@zjcc.org.cn

Li Yuan, Professor

CONTACT

+86-15558103169; yuanli2768@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretary of the party committee

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)