Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer

Completed

• Conditions: Gastric Cancer
• Interventions: Other: Observational study

• Registration Number: NCT03314649
• Lead Sponsor: Fudan University

Brief Summary

Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer.

Detailed Description

Gastric cancer (GC) remains one of the most common causes of cancer-related mortality worldwide. Surgery has always been considered as the most effective treatment for GC. Peritoneal metastasis is the common pattern of postoperative recurrence, especially patients with T4 stage or serosal invasion. What is worse, patients with peritoneal metastasis have a poor prognosis. However, it is often difficult to diagnose peritoneal metastasis at an early stage. As we know, the implantation of peritoneal free cancer cells exfoliating from serosa-invasive tumors is main reason of peritoneal seeding. Cytological examination of peritoneal lavage fluid is always performed to predict peritoneal micrometastases. However, more than half of patients with negative cytological results develop peritoneal recurrence. Low sensitivity and poor negative predictive value of this method have heralded the development of advanced techniques in detecting peritoneal free cancer cells.

In this study, novel genetic techniques will be used to detect mutated DNA of shed cancer cells in abdominal cavity. The present clinical trial aims to find a better tool to detect abdominal micrometastasis in GC patients, which may become a valid clinical index to predict postoperative relapse and direct treatment.

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Study Start: 2017-12-21
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

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

Inclusion Criteria

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
2. PS (ECOG) of 0 or 1 and expected to survive more than 6 months.
3. Written informed consent from the patient.
4. Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.

Exclusion Criteria

1. Female in pregnancy or lactation. 2. Patients participating in any other clinical trials currently，or participated in other trails within 1 months. 3. Patients with poor compliance or considered to be poor compliance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational study	Observational study	Patients with gastric cancer and non-cancerous disease planned to have laparotomy

Primary Outcome Measures

Name	Time	Method
prognostic molecular markers	3-year	prognostic molecular markers

Secondary Outcome Measures

Name	Time	Method
OS	3-year	Overall survival
DFS	3-year	Disease-free survival

Trial Locations

Locations (1)

Cancer Center of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China