Methylation Analysis of Circulating Tumor DNA in Gastric Cancer
1 other identifier
observational
540
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 13, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedAugust 13, 2020
August 1, 2020
3 years
August 10, 2020
August 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
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.
gastric cancer
This group will include 380 patients with gastric cancer and the diagnoses will be based on British Society of Gastroenterology guidelines.
Interventions
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.
Eligibility Criteria
Patients who have been referred to the participating study sites for upper GI endoscopy for standard clinical indications.
You may qualify if:
- The subject is scheduled to undergo an endoscopy because of medical indications.
- 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.
- The subject must be willing and able to comply with all study procedures.
You may not qualify if:
- The subject who is unable to undergo gastroscopy.
- The subject with previous total or partial gastrectomy.
- 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.
- The subject is unwilling or unable to provide signed informed consent.
- The subject who is pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 30207593BACKGROUNDDiaz 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.
PMID: 24449238BACKGROUNDKilgour 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.
PMID: 32289272BACKGROUNDGao 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.
PMID: 28009985BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 13, 2020
Study Start
October 1, 2020
Primary Completion
September 30, 2023
Study Completion
May 1, 2025
Last Updated
August 13, 2020
Record last verified: 2020-08