- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01824966
Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma (SRCC)
Signet Ring Cells in Esophageal and GE Junction Carcinomas Have a More Aggressive Biological Behavior
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- University Hospital Leuven; Dept. of Thoracic Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adenocarcinoma R0 resection Primary surgery
Exclusion Criteria:
- Other histology R1 or R2 resection Neoadjuvant therapy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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SRC<50%
Adenocarcinoma containing < 50% of signet ring cells
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SRC>50%
Adenocarcinoma containing > 50% of signet ring cells
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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
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Cancer specific 5 year survival classified into two groups according to WHO criteria (>50% SRC or <50% SRC)
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from surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Philippe Nafteux, MD, University Hospital Leuven; Dept. of Thoracic Surgery
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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