Prognostic Clinical Trial
Official title:
Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?
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.
stomach cancer signet ring cell carcinoma prognosis chemotherapy ;
Observational Model: Case Control, Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04354558 -
French Single Centre Experience of Critically Ill Patients With Covid 19
|
||
Completed |
NCT05501613 -
Early Multimodal Neuromonitoring For Spontaneous Intracerebral Hemorrhage (ICH)
|
||
Not yet recruiting |
NCT06299215 -
Factors and Prognosis of Obstructive Pyelonephritis Patients
|