Serum and Peritoneal CEA and CA 19-9 for Gastric Adenocarcinoma

Completed

• Conditions: Gastric Adenocarcinoma
• Interventions: Procedure: gastrectomy; Procedure: sampling of peritoneal washing aspirate

• Registration Number: NCT02801955
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor markers.

Detailed Description

Clinical usage of tumor markers on preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma is a controversial issue. It has been thought that there is a positive correlation between serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 and pathologic features of gastric tumors and peritoneal dissemination.

In this study, it was aimed to evaluate the effect of serum and peritoneal CEA and CA 19-9 to predict TNM stages and peritoneal washing cytology in patients with gastric adenocarcinoma after curative gastrectomy, and to determine predictive value of these measurements to the development of recurrence and death.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-16
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Endoscopically proven gastric adenocarcinoma
• Standard gastrectomy and a D2 lymph node dissection;
• Desire to attend the study protocol

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Exclusion Criteria

• Metastatic or overt peritoneal disseminated cancer
• Undesired reaction to attend the study protocol

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tumor marker	gastrectomy	serum CEA and CA 19-9 levels in patients with curative gastrectomy preoperatively and peritoneal CEA and CA 19-9 levels in patients taken at the beginning of curative gastrectomy via sampling of peritoneal washing aspirate
tumor marker	sampling of peritoneal washing aspirate	serum CEA and CA 19-9 levels in patients with curative gastrectomy preoperatively and peritoneal CEA and CA 19-9 levels in patients taken at the beginning of curative gastrectomy via sampling of peritoneal washing aspirate

Primary Outcome Measures

Name	Time	Method
TNM stage	through pathologic report completion, an average of 1 month	TNM stage based on the 7th American Joint Committee on Cancer/International Union Against Cancer tumor, node, metastasis system.

Secondary Outcome Measures

Name	Time	Method
recurrence/death	through follow-up period, an average of 24 months	detection of recurrence or development of death
peritoneal washing cytology	through pathologic report completion, an average of 1 month	detection of positive free peritoneal gastric adenocarcinoma cells.

Trial Locations

Locations (1)

Mustafa Hasbahceci; 🇹🇷 Istanbul, Turkey