Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma (SRCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01824966
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):
Johnny Moons, University Hospital, Gasthuisberg

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease
Adenocarcinoma Esophageal Cancer

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Signet Ring Cells in Esophageal and GE Junction Carcinomas Have a More Aggressive Biological Behavior
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

- Adenocarcinoma R0 resection Primary surgery

Exclusion Criteria:

- Other histology R1 or R2 resection Neoadjuvant therapy

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824966


Locations
Layout table for location information
Belgium
University Hospital Leuven; Dept. of Thoracic Surgery
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Layout table for investigator information
Principal Investigator: Philippe Nafteux, MD University Hospital Leuven; Dept. of Thoracic Surgery
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Johnny Moons, RN, MSc, Datamanager, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01824966     History of Changes
Other Study ID Numbers: SRCC
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013
Keywords provided by Johnny Moons, University Hospital, Gasthuisberg:
Esophagectomy
Signet Ring Cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms