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Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

NCT01249859 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2014-12-09

No results posted yet for this study

Summary

Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries

* Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.
* Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring cell adenocarcinomas.

Primary objective To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract

Secondary objectives

* Impact of neoadjuvant CT on overall survival
* Impact and differential diagnostic value of linitis
* R0 resection rates
* 3 years recurrence free survival
* Overall 3 years survival
* Prognostic factors
* Prognostic value of the presence of a minority quota of signet ring cell
* Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients
* Tolerance of (radio) chemotherapy for ADCI

Methodology Intention to treat retrospective case-control multicentric study A pairing on demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be done to ensure comparability in case control study groups.

Inclusion criteria All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.

For whom the first consultation took place between January 1997 and January 2010

Exclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach

Planned study period The data will be collected over a period from January 1997 to January 2010.

The objective is to complete the data collection for summer 2010.

Conditions

  • Signet Ring Cell Carcinoma
  • Stomach Disease
  • Oesophagus
  • Prognostic
  • Case-control Study

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • christophe mariette, MD, PhD · CHU lille

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01249859 on ClinicalTrials.gov