Molecular Analysis in Peritoneal Washing Citology for Locally Advanced Gastric Cancer

• Conditions: Polymerase Chain Reaction; Gastric Cancer

• Registration Number: NCT03098758
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

Gastric carcinoma is a disease with a high mortality. Peritoneal washing cytology has a recognized prognostic utility. However sensibility of this study is not appropriate. Studies with PCR (polymerase chain retrotranscription) can increase sensibility and accurate staging information.

Objective: To analyze the sensibility and specificity of the expression of CK20, CEA and Ber-EP4 with PCR technique in peritoneal washings of advanced gastric carcinoma without clinical evidence of peritoneal carcinomatosis.

Methodology: Retrotranscription analysis (RT-PCR) and quantitative PCR (qPCR) of CK20, CEA and Ber-EP4 in peritoneal washing. Test the feasibility of qPCR with this new marker (Ber-EP4). Comparison of the results with data obtained with conventional cytology. Study of peritoneal recurrence.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Start: 2017-05-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with resectable advanced gastric cancer
• Informed consent

Exclusion Criteria

• Macroscopic peritoneal carcinomatosis
• Non operable patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
specific markers in peritoneal cells	during surgical intervention	Detection of CK20, CEA and BER-EP4 by PCR technique in peritoneal washing of advanced gastric cancer

Trial Locations

Locations (1)

Parc Tauli Hospital Universitari; 🇪🇸 Sabadell, Barcelona, Spain