Methylation Analysis of Circulating Tumor DNA in Gastric Cancer
NCT ID: NCT04511559
Last Updated: 2020-08-13
Study Results
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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UNKNOWN
540 participants
OBSERVATIONAL
2020-10-01
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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chronic gastritis
This group will include 80 patients with chronic gastritis and the diagnoses will be based on the British Society of Gastroenterology guidelines.
Circulating Tumor DNA Methylation Sequencing
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
tissue DNA Methylation Sequencing
Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.
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.
Circulating Tumor DNA Methylation Sequencing
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
tissue DNA Methylation Sequencing
Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.
gastric cancer
This group will include 380 patients with gastric cancer and the diagnoses will be based on British Society of Gastroenterology guidelines.
Circulating Tumor DNA Methylation Sequencing
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
tissue DNA Methylation Sequencing
Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.
Interventions
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Circulating Tumor DNA Methylation Sequencing
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
tissue DNA Methylation Sequencing
Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.
Eligibility Criteria
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Inclusion Criteria
2. The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
3. The subject must be willing and able to comply with all study procedures.
Exclusion Criteria
2. The subject with previous total or partial gastrectomy.
3. The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.
4. The subject is unwilling or unable to provide signed informed consent.
5. The subject who is pregnant.
18 Years
75 Years
ALL
Yes
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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ZS-DL-202001
Identifier Type: -
Identifier Source: org_study_id
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