Completed

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

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Carcinoma+10

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Gasthuisberg
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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).

Principal SponsorUniversity Hospital, Gasthuisberg
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

82 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaDigestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialAdenocarcinomaEsophageal Neoplasms

Criteria

Inclusion Criteria: - Adenocarcinoma R0 resection Primary surgery Exclusion Criteria: - Other histology R1 or R2 resection Neoadjuvant therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital Leuven; Dept. of Thoracic Surgery

Leuven, BelgiumOpen University Hospital Leuven; Dept. of Thoracic Surgery in Google Maps
CompletedOne Study Center