Detection of Peritoneal Metastasis of Gastric Cancer by Liquid Biopsy in Peripheral Blood: A Prospective Study

Recruiting now

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT05347524

Run by

Shanghai Zhongshan Hospital

People needed

384

Starts

2022-03-01

Expected to finish

2030-06-30

Last updated by the study team

2022-04-26

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria for Case Arm Participants:
• Age 18-74 years at the day of consenting to the study.
• Able to provide a written informed consent.
• 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.
• Diagnosis of peritoneal metastasis by laparoscopy with cytology.
• Inclusion Criteria for Control Arm Participants:
• Age 18-74 years at the day of consenting to the study.
• Able to provide a written informed consent.
• 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.
• No peritoneal metastasis detected by laparoscopy with cytology.

You may not qualify if…

• Exclusion Criteria for All Participants:
• Insufficient qualified blood samples.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
• With other known malignant tumors or multiple primary tumors.
• Exclusion Criteria for Control Arm Participants:
• Insufficient qualified blood samples.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
• With other known malignant tumors or multiple primary tumors.

Where it is running

• ZhongShan Hospital, Fudan university, Shanghai, China — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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