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

Gastric Cancer Clinical Trial

Official title:

Prospective Observational Study of Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314649
• Other study ID #: CGCG003
• Status: Completed
• Start date: December 21, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Gastric Cancer
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Other:
• Observational study
Lavage of the Peritoneal Cavity

Locations

Country	Name	City	State
China	Cancer Center of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prognostic molecular markers	prognostic molecular markers	3-year
Secondary	OS	Overall survival	3-year
Secondary	DFS	Disease-free survival	3-year