Prognosis of Signet Ring Cells in Upper Digestive Neoplasms (ADCI001)
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|ClinicalTrials.gov Identifier: NCT01249859|
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : December 9, 2014
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
- 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.
|Condition or disease|
|Signet Ring Cell Carcinoma Stomach Disease Oesophagus Prognostic Case-control Study|
|Study Type :||Observational|
|Actual Enrollment :||2500 participants|
|Observational Model:||Case Control|
|Official Title:||Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||December 2010|
|Signet ring cell carcinoma|
|non signet ring cell adenocarcinoma|
- 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 ]
- 3 year recurrence free survival [ Time Frame: participants are followed until recurrence or time point at 31 september 2010 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249859
|University Hospital of Lille|
|Lille, France, 59037|
|Study Director:||christophe mariette, MD, PhD||CHU lille|