An observational study in Gastric Cancer and Healthy, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Zhejiang Cancer Hospital · Observational
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.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 281 across 684 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 281 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
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Exclusion Criteria:
Other: No intervention
Other: No intervention
No intervention measures are needed.
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.
Time frame: First day in hospital
Plan to share: No — This study does not involve clinical trials of drugs; it is solely designed to ensure the confidentiality of patient information. For participant information (such as names and ages), a coding system will be used instead of real names. After enrollment, each case will be assigned an enrollment number. Throughout the entire study, only the main researchers within the research team will have access to participants' real personal data (names, ages) in the electronic database. Distribution and sharing are prohibited. During the publication of articles, the main researchers within the research team will replace participant privacy information (names) with sample codes to achieve de-identification. Furthermore, the protection of participants' personal information will be maintained throughout the study, and any dissemination or leakage is strictly prohibited.
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Dec 2025, 57 months after the start.
Of 274 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 171. This study's planned 57 months is close to that.
Counting every sponsor, half of 305 studies reached it within 56 months; a quarter within 30 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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