Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma (SRCC)

April 4, 2013 updated by: Johnny Moons, University Hospital, Gasthuisberg

Signet Ring Cells in Esophageal and GE Junction Carcinomas Have a More Aggressive Biological Behavior

There has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).

Study Overview

Status

Completed

Conditions

Detailed Description

Adenocarcinoma (ADC) of the esophagus and gastroesophageal junction (GEJ) is an aggressive neoplasm and has a poor prognosis. Surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma.

Signet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (SRC)). According to the World Health Organisation (WHO), a true signet-ring cell carcinoma (SRCca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of SRC in the stroma. If the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (ADC).

Study Type

Observational

Enrollment (Actual)

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

Belgium
- - Leuven, Belgium, 3000
    - University Hospital Leuven; Dept. of Thoracic Surgery

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From our prospectively built database we retrieved all adenocarcinoma from 1990 till 2009 who underwent primary surgery with R0 resection. Seven hundred seventy-nine patients were included for further analysis. Pathology reports mentioning signet ring cells (n = 82) were reviewed by our pathologist and, after confirmation, tumors were classified into two groups according to WHO criteria (>50% SRC or <50% SRC). The remaining 697 ADC patients served as control group.

Description

Inclusion Criteria:

- Adenocarcinoma R0 resection Primary surgery

Exclusion Criteria:

- Other histology R1 or R2 resection Neoadjuvant therapy

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

Observational Models: Cohort
Time Perspectives: Retrospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
SRC<50% Adenocarcinoma containing < 50% of signet ring cells
SRC>50% Adenocarcinoma containing > 50% of signet ring cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer specific 5 year survival in SRCC Time Frame: from surgery	Cancer specific 5 year survival classified into two groups according to WHO criteria (>50% SRC or <50% SRC)	from surgery

Collaborators and Investigators

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

Sponsor

University Hospital, Gasthuisberg

Investigators

Principal Investigator: Philippe Nafteux, MD, University Hospital Leuven; Dept. of Thoracic Surgery

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

March 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)