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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03314649
Enrollment
200
Registered
2017-10-19
Start date
2017-12-21
Completion date
2019-01-01
Last updated
2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Peritoneal Lavage, Gene Mutation, Peritoneal Metastasis,Gastric Cancer

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.

Interventions

OTHERObservational study

Lavage of the Peritoneal Cavity

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
prognostic molecular markers3-yearprognostic molecular markers

Secondary

MeasureTime frameDescription
OS3-yearOverall survival
DFS3-yearDisease-free survival

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026