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The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
Gastric cancer represents one of the common malignant tumors in China, with high incidence and mortality rates. Surgery is the conventional treatment option for early and intermediate stage gastric cancer, but the diagnosis in the early stage of gastric cancer remains a challenge to clinical practitioners. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell-free DNA (cfDNA) of other sources in blood circulation. ctDNA is reflecting the most up-to-date status of the tumor genome. Hence, it is considered as a novel biomarker for tumors, which can be qualitative, quantitative, and used for disease monitoring. This study is designed to evaluate the potential clinical utility of circulating tumor DNA (ctDNA) as a clinical index in the diagnosis and prognosis of gastric cancer. The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronic gastritis | This group will include 80 patients with chronic gastritis and the diagnoses will be based on the British Society of Gastroenterology guidelines. |
| |
| Moderate to severe atrophy/intestinal metaplasia/ | This group will include 80 patients with Moderate to severe atrophy/intestinal metaplasia/ and the diagnoses will be based on British Society of Gastroenterology guidelines. |
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| gastric cancer | This group will include 380 patients with gastric cancer and the diagnoses will be based on British Society of Gastroenterology guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circulating Tumor DNA Methylation Sequencing | Diagnostic Test | Whole blood collection through venipuncture. DNA methylation levels by deep sequencing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer. | We will develop the linear model and a threshold value differentiating gastric cancer from control based on the 100 patient training set. | 1-2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been referred to the participating study sites for upper GI endoscopy for standard clinical indications.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Dong, M.D. & Ph.D. | Contact | +8613916877798 | dong.ling@zs-hospital.sh.cn | |
| Ji-Min Zhu, M.D. & Ph.D. | Contact | +8613611867273 | zhu.jimin@zs-hospital.sh.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207593 | Background | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. | |
| 24449238 | Background | Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| tissue DNA Methylation Sequencing | Diagnostic Test | Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing. |
|
| 32289272 | Background | Kilgour E, Rothwell DG, Brady G, Dive C. Liquid Biopsy-Based Biomarkers of Treatment Response and Resistance. Cancer Cell. 2020 Apr 13;37(4):485-495. doi: 10.1016/j.ccell.2020.03.012. |
| 28009985 | Background | Gao Y, Zhang K, Xi H, Cai A, Wu X, Cui J, Li J, Qiao Z, Wei B, Chen L. Diagnostic and prognostic value of circulating tumor DNA in gastric cancer: a meta-analysis. Oncotarget. 2017 Jan 24;8(4):6330-6340. doi: 10.18632/oncotarget.14064. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |