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Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01249859
Acronym
ADCI001
Enrollment
2500
Registered
2010-11-30
Start date
2010-03-31
Completion date
2010-12-31
Last updated
2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Case-control Study, Oesophagus, Prognostic, Signet Ring Cell Carcinoma, Stomach Disease

Keywords

stomach disease, signet ring cell carcinoma, chemotherapy, Prognostic

Brief 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.

Detailed description

stomach cancer signet ring cell carcinoma prognosis chemotherapy

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 tractparticipants are followed until death or time point at 31 september 2010

Secondary

MeasureTime frame
3 year recurrence free survivalparticipants are followed until recurrence or time point at 31 september 2010
Overall 3 year survival according to tumor stage, node invasion, and tumor localizationparticipants are followed until death or time point at 31 september 2010

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026