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Completed

NCT Number: NCT02801955

Serum and Peritoneal CEA and CA 19-9 for 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.

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Key information

Conditions

Gastric Adenocarcinoma

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mustafa Hasbahceci

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gastrectomy

Procedure

radical total/subtotal gastrectomy with D2 lymph node dissection

sampling of peritoneal washing aspirate

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. peritoneal washing cytology

    Time frame: through pathologic report completion, an average of 1 month

    detection of positive free peritoneal gastric adenocarcinoma cells.

  2. recurrence/death

    Time frame: through follow-up period, an average of 24 months

    detection of recurrence or development of death

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 16, 2016
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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