Skip to main content
OpenTrials
Completed

NCT Number: NCT03314649

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Center of Sun Yat-sen University

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

-

Treatment and study plan

observational study

Other

Lavage of the Peritoneal Cavity

Primary outcomes

  1. prognostic molecular markers

    Time frame: 3-year

    prognostic molecular markers

Secondary outcomes

  1. OS

    Time frame: 3-year

    Overall survival

  2. DFS

    Time frame: 3-year

    Disease-free survival

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2017
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.