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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03314649
Recruitment Status : Completed
First Posted : October 19, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dazhi Xu, Fudan University

Study Description
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Brief Summary:
Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer.

Condition or disease Intervention/treatment
Gastric Cancer Other: Observational study

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 Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational study
Patients with gastric cancer and non-cancerous disease planned to have laparotomy
 Other: Observational study
Lavage of the Peritoneal Cavity


Outcome Measures
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Primary Outcome Measures :
  1. prognostic molecular markers [ Time Frame: 3-year ]
    prognostic molecular markers


Secondary Outcome Measures :
  1. OS [ Time Frame: 3-year ]
    Overall survival

  2. DFS [ Time Frame: 3-year ]
    Disease-free survival


Biospecimen Retention:   Samples With DNA
tumor biopsy, peritoneal lavage

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.
Criteria

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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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314649


Locations
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China, Guangdong
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Dazhi Xu, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03314649    
Other Study ID Numbers: CGCG003
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dazhi Xu, Fudan University:
Peritoneal Lavage, Gene Mutation, Peritoneal Metastasis,Gastric Cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Stomach Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases