CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,500 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01249859
NCT01249859N/ACompleted

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

University Hospital, Lille·observational·Posted Nov 30, 2010·Updated Dec 9, 2014

In Brief

An observational study for Signet Ring Cell Carcinoma and 4 related conditions. Completed, enrolled 2,500 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.6 years ago