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

NCT ID: NCT05991947

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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gastric cancer patients

No intervention

Intervention Type OTHER

No intervention measures are needed.

healthy individuals

No intervention

Intervention Type OTHER

No intervention measures are needed.

Interventions

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No intervention

No intervention measures are needed.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangdong Cheng

Secretary of the party committee

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangdong Cheng, Professor

Role: CONTACT

+86-13968032995

Li Yuan, Professor

Role: CONTACT

+86-15558103169

Facility Contacts

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Xiangdong Cheng, PhD.

Role: primary

+0086-0571-88128041

Other Identifiers

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IRB-2023-427

Identifier Type: -

Identifier Source: org_study_id

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