Clinical trial NCT05991947: Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
Official title: Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Healthy
Keywords: Gastric Cancer
Proteomics
Diagnostic model
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Differences in ctDNA gene and tumor-specific proteins expression
timeFrame: First day in hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
state: Zhejiang
Study officials:
References: