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

NCT ID: NCT03314649

Last Updated: 2019-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-21

Study Completion Date

2019-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational study

Patients with gastric cancer and non-cancerous disease planned to have laparotomy

Observational study

Intervention Type OTHER

Lavage of the Peritoneal Cavity

Interventions

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Observational study

Lavage of the Peritoneal Cavity

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Dazhi Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Center of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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CGCG003

Identifier Type: -

Identifier Source: org_study_id

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