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Trial Title:
Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
NCT ID:
NCT05991947
Condition:
Gastric Cancer
Healthy
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
Proteomics
Diagnostic model
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention measures are needed.
Arm group label:
gastric cancer patients
Arm group label:
healthy individuals
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.
Criteria for eligibility:
Study pop:
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)
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangdong Cheng, PhD.
Phone:
+0086-0571-88128041
Email:
chengxd516@126.com
Start date:
March 1, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991947
