Methylation Analysis of Circulating Tumor DNA in Gastric Cancer

August 10, 2020 updated by: Shanghai Zhongshan Hospital

Methylation Analysis of Circulating Tumor DNA in Early Diagnosis and Prognostic Stratification in Patients With 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been referred to the participating study sites for upper GI endoscopy for standard clinical indications.

Description

Inclusion Criteria:

  1. The subject is scheduled to undergo an endoscopy because of medical indications.
  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:

  1. The subject who is unable to undergo gastroscopy.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic gastritis
This group will include 80 patients with chronic gastritis and the diagnoses will be based on the British Society of Gastroenterology guidelines.
Diagnostic test: Circulating Tumor DNA Methylation Sequencing
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
Diagnostic test: 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.
Diagnostic test: Circulating Tumor DNA Methylation Sequencing
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
Diagnostic test: 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.
Diagnostic test: Circulating Tumor DNA Methylation Sequencing
Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
Diagnostic test: tissue DNA Methylation Sequencing
Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer.
Time Frame: 1-2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-DL-202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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