Cancer
Conditions
Keywords
stomach neoplasms, peritoneal metastasis, liquid biopsy, cell-free DNA (cfDNA) methylation
Brief summary
This study is a prospective, multi-omics, observational study aimed at detecting peritoneal metastasis of gastric cancer by combined assays for methylation of cell-free DNA (cfDNA) and other blood-based biomarkers. The study will enroll 384 participants with gastric cancer.
Detailed description
Peritoneal metastasis (PM) in gastric cancer is associated with a poor prognosis. Laparoscopy with cytology is performed to evaluate for peritoneal spread when considering chemoradiation or surgery. However, the laparoscopy is invasive and the sensitivity of computed tomography (CT) scan is poor for detecting PM. Therefore, it is necessary to evaluate the feasibility of cfDNA methylation and other blood-based biomarkers for the PM diagnosis. The study will enroll 384 participants with gastric cancer. Baseline blood and diagnosis of PM by laparoscopy with cytology will be collected. Participants with PM will be defined as the case arm and participants without PM will be defined as the control arm. A PM diagnostic model will be developed.
Interventions
OTHERBaseline blood draw and blood-based biomarkers analyses
Baseline blood draw and blood-based biomarkers analyses
Sponsors
Guangzhou Burning Rock Bioengineering Ltd.
Shanghai Zhongshan Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria for Case Arm Participants: 1. Age 18-74 years at the day of consenting to the study. 2. Able to provide a written informed consent. 3. No prior cancer treatment (local or systematic) with either of the following: A. Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw. B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw. 4. Diagnosis of peritoneal metastasis by laparoscopy with cytology. * Inclusion Criteria for Control Arm Participants: 1. Age 18-74 years at the day of consenting to the study. 2. Able to provide a written informed consent. 3. No prior cancer treatment (local or systematic) with either of the following: A. Pathologically confirmed gastric cancer diagnosis within 42 days prior to blood draw. B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw. 4. No peritoneal metastasis detected by laparoscopy with cytology.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the cfDNA methylation-based model in detecting peritoneal metastasis of gastric cancer. | 30 months |
| Sensitivity and specificity of a cfDNA methylation-based model, in combination with other biomarkers, for detecting peritoneal metastasis of gastric cancer. | 30 months |
Countries
China
Contacts
Primary ContactYihong Sun, Ph. D
Backup ContactXuefei Wang, Ph. D
Outcome results
None listed