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

June 13, 2017 updated by: Mustafa Hasbahceci, Bezmialem Vakif University

Predictive Value of Serum and Peritoneal CEA and CA 19-9 for TNM Stage and Peritoneal Dissemination of Gastric Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Mustafa Hasbahceci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

gastric adenocarcinoma treated with curative gastrectomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
tumor marker
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
Procedure: gastrectomy
radical total/subtotal gastrectomy with D2 lymph node dissection
Procedure: sampling of peritoneal washing aspirate
After thoroughly examination of the peritoneal cavity revealing the absence of peritoneal dissemination, the peritoneal cavity was washed with 200 ml of saline, and at least one third was aspirated from several regions of the peritoneal cavity, including near the primary tumor, the left and right subphrenic areas and the pouch of Douglas with suction tubes to a clean bottle and designated as the peritoneal sample for determination of peritoneal levels of CEA and CA 19-9.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNM stage
Time Frame: 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.
through pathologic report completion, an average of 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: mustafa hasbahceci, assoc. prof., Bezmialem Vakif University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GastCancTmMark2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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