Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

This group will include 80 patients with chronic gastritis and the diagnoses will be based on the British Society of Gastroenterology guidelines.

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.

This group will include 380 patients with gastric cancer and the diagnoses will be based on British Society of Gastroenterology guidelines.

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

Circulating Tumor DNA Methylation Sequencing

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

tissue DNA Methylation Sequencing

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

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

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.

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.

Methylation Analysis of Circulating Tumor DNA in Gastric Cancer

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

We will develop the linear model and a threshold value differentiating gastric cancer from control based on the 100 patient training set.

Shanghai Zhongshan Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.

Sang-Won Um, MD, PhD

This study aims to investigate the utility of circulating tumor DNA (ctDNA) methylation sequencing in the diagnosis of primary lung cancer.

Plasma sample of patients with and without lung cancer will be collected and analyzed using methylation-sensitive enzyme sequencing method. Diagnostic performance of ctDNA methylation sequencing will be compared with that of tumor markers (CEA, Cyfra 21-1, and NSE) combined.

Liquid Biopsy Using Methylation Sequencing for Lung Cancer

Clinical Utility of Circulating Tumor DNA Methylation in the Diagnosis of Primary Lung Cancer

Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of ctDNA methylation will be compared with that of tumor markers.

Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of ctDNA methylation will be compared with that of tumor markers.

Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of ctDNA methylation will be compared with that of tumor markers.

Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of ctDNA methylation will be compared with that of tumor markers.

Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of ctDNA methylation will be compared with that of tumor markers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Methylation Analysis of Circulating Tumor DNA in Gastric Cancer	NCT04511559	Stomach Neoplas... Circulating Tum...	Circulating Tum... tissue DNA Meth...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Liquid Biopsy Using Methylation Sequencing for Lung Cancer	NCT04253509	Lung Cancer Diagnoses Disea...	Circulating Tum...	15 Years - 85 Years	Samsung Medical Center

Spots Global Cancer Trial Database for circulating tumor dna methylation sequencing