Methylation Analysis of Circulating Tumor DNA in Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04511559
• Other study ID #: ZS-DL-202001
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: May 1, 2025

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Ling Dong, M.D. & Ph.D.
• Phone: +8613916877798
• Email: dong.ling[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: May 1, 2025
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Circulating Tumor DNA
• Stomach Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

References & 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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