Methylation Analysis of Circulating Tumor DNA in Gastric Cancer

NCT ID: NCT04511559

Last Updated: 2020-08-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stomach Neoplasms Circulating Tumor DNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.

tissue DNA Methylation Sequencing

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.

tissue DNA Methylation Sequencing

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.

tissue DNA Methylation Sequencing

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

tissue DNA Methylation Sequencing

Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ling Dong, M.D. & Ph.D.

Role: CONTACT

+8613916877798

Ji-Min Zhu, M.D. & Ph.D.

Role: CONTACT

+8613611867273

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.

Reference Type BACKGROUND
PMID: 30207593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24449238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32289272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28009985 (View on PubMed)

Other Identifiers

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ZS-DL-202001

Identifier Type: -

Identifier Source: org_study_id

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