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Completed

NCT Number: NCT01249859

Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

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.

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Key information

About this study

stomach cancer signet ring cell carcinoma prognosis chemotherapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • As they benefit from a medical and/or surgical support (primitive cancer being or not resected), whatever the metastatic or the recurrence situation was.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: participants are followed until death or time point at 31 september 2010

Secondary outcomes

  1. 3 year recurrence free survival

    Time frame: participants are followed until recurrence or time point at 31 september 2010

  2. Overall 3 year survival according to tumor stage, node invasion, and tumor localization

    Time frame: participants are followed until death or time point at 31 september 2010

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?

Acronym: ADCI001

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 30, 2010
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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