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

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05991947

Collaborator

(none)

1,100

Enrollment

Location

Anticipated Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Healthy	Other: No intervention

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
gastric cancer patients	Other: No intervention No intervention measures are needed.
healthy individuals	Other: No intervention No intervention measures are needed.

Arm

Intervention/Treatment

gastric cancer patients

Other: No intervention

No intervention measures are needed.

healthy individuals

Other: No intervention

No intervention measures are needed.

Outcome Measures

Primary Outcome Measures

Differences in ctDNA gene and tumor-specific proteins expression [First day in hospital]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiangdong Cheng, Secretary of the party committee, Zhejiang Cancer Hospital

ClinicalTrials.gov Identifier:

NCT05991947

Other Study ID Numbers:

IRB-2023-427

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiangdong Cheng, Secretary of the party committee, Zhejiang Cancer Hospital

Gastric Cancer

Proteomics

Diagnostic model

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Aug 15, 2023