Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma

Esophageal Cancer Clinical Trial

— SRCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824966
• Other study ID #: SRCC
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 4, 2013
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adenocarcinoma R0 resection Primary surgery

Exclusion Criteria:

• Other histology R1 or R2 resection Neoadjuvant therapy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
Belgium	University Hospital Leuven; Dept. of Thoracic Surgery	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer specific 5 year survival in SRCC	Cancer specific 5 year survival classified into two groups according to WHO criteria (>50% SRC or <50% SRC)	from surgery	No