University Hospital of Lille
Lille, 59037, France
NCT Number: NCT01249859
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.
Looking for future studies?
Notify Me18 year–95 year
All sexes
Observational
Lille, 59037, France
stomach cancer signet ring cell carcinoma prognosis chemotherapy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: participants are followed until death or time point at 31 september 2010
Time frame: participants are followed until recurrence or time point at 31 september 2010
Time frame: participants are followed until death or time point at 31 september 2010
University Hospital, Lille
Other
Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?
Acronym: ADCI001
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.
Published trials that share one or more normalized conditions with this study.
NCT01741363
Colonic Diseases, Colorectal Cancer
Taipei, Taiwan
View Trial DetailsNCT06958250
Digestive System Diseases, Gastric Disease
Plainsboro, New Jersey, United States
View Trial DetailsNCT06299215
Acute Kidney Injury, Acute Lung Injury
Paris, France
View Trial DetailsNCT07304310
Case-control Study, Debonding
Milan, Italy
View Trial Details