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SRCC: Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma

Sponsor
University Hospital, Gasthuisberg (Other)
Overall Status
Completed
CT.gov ID
NCT01824966
Collaborator
(none)
82
Enrollment
1
Location
9
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Mar 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    SRC<50%

    Adenocarcinoma containing < 50% of signet ring cells
    SRC>50%

    Adenocarcinoma containing > 50% of signet ring cells

    Outcome Measures

    Primary Outcome Measures

    1. Cancer specific 5 year survival in SRCC [from surgery]

      Cancer specific 5 year survival classified into two groups according to WHO criteria (>50% SRC or <50% SRC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adenocarcinoma R0 resection Primary surgery
    Exclusion Criteria:
    • Other histology R1 or R2 resection Neoadjuvant therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Leuven; Dept. of Thoracic Surgery Leuven Belgium 3000

    Sponsors and Collaborators

    • University Hospital, Gasthuisberg

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johnny Moons, RN, MSc, Datamanager, University Hospital, Gasthuisberg
    ClinicalTrials.gov Identifier:
    NCT01824966
    Other Study ID Numbers:
    • SRCC
    First Posted:
    Apr 5, 2013
    Last Update Posted:
    Apr 5, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Johnny Moons, RN, MSc, Datamanager, University Hospital, Gasthuisberg
    Esophagectomy
    Signet Ring Cells
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Apr 5, 2013