Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer

• Conditions: Metastasis; Stomach Neoplasms
• Interventions: Diagnostic Test: CTC test; Diagnostic Test: ctDNA test

• Registration Number: NCT05208372
• Lead Sponsor: First Hospital of China Medical University

Brief Summary

To investigate the value of CTCs and ctDNA in the diagnosis of metastasis in ascites/peritoneal flushing fluid and blood; To investigate the influence of laparoscopic CO2 pneumoperitoneum establishment on peritoneal and hematogenous metastasis of advanced gastric cancer; To explore the influence of the number and type of CTCs and ctDNA on metastasis and prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Primary Completion: 2023-02-01
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients who sign informed consent.
2. Gastric cancer is determined by more than 2 pathologists.
3. Patients with Borrmann III/IV gastric cancer.

Exclusion Criteria

1. Patients who complicate with other malignant tumors.
2. Patients who complicate with other serious heart and lung diseases.
3. Patients who receive preoperative neoadjuvant chemotherapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparotomy group	CTC test	Patients who undergo radical laparotomy for gastric cancer.
Laparoscopy group	CTC test	Patients who undergo laparoscope-assisted radical gastrectomy for gastric cancer.
Laparoscopy group	ctDNA test	Patients who undergo laparoscope-assisted radical gastrectomy for gastric cancer.
Laparotomy group	ctDNA test	Patients who undergo radical laparotomy for gastric cancer.

Primary Outcome Measures

Name	Time	Method
Quantity of CTCs	1 day	To count the circulating tumor cells in ascites and blood.
Classification of CTCs	1 day	To classify the circulating tumor cells in ascites and blood.
Expression of ctDNA	1 day	To assess the expression of circulating tumor DNA in ascites and blood, including YAP1, LAMC1 and DDIT4.

Trial Locations

Locations (2)

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

First Hospital of Jinzhou Medical University; 🇨🇳 Jinzhou, Liaoning, China