NCT01824966

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

9 months

First QC Date

April 2, 2013

Last Update Submit

April 4, 2013

Conditions

AdenocarcinomaEsophageal Cancer

Keywords

EsophagectomySignet Ring Cells

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

SRC<50%

Adenocarcinoma containing \< 50% of signet ring cells

SRC>50%

Adenocarcinoma containing \> 50% of signet ring cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Adenocarcinoma R0 resection Primary surgery

You may not qualify if:

  • \- Other histology R1 or R2 resection Neoadjuvant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven; Dept. of Thoracic Surgery

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

AdenocarcinomaEsophageal Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Philippe Nafteux, MD

    University Hospital Leuven; Dept. of Thoracic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MSc, Datamanager

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 5, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

BE(1)