ADCI001: Prognosis of Signet Ring Cells in Upper Digestive Neoplasms

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT01249859

Collaborator

(none)

2,500

Enrollment

Location

Duration (Months)

276.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Signet Ring Cell Carcinoma Stomach Disease Oesophagus Prognostic Case-control Study

Detailed Description

stomach cancer signet ring cell carcinoma prognosis chemotherapy

Study Design

Study Type:

Observational

Actual Enrollment :

2500 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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 :

Mar 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Signet ring cell carcinoma
non signet ring cell adenocarcinoma

Outcome Measures

Primary Outcome Measures

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 [participants are followed until death or time point at 31 september 2010]

Secondary Outcome Measures

3 year recurrence free survival [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 [participants are followed until death or time point at 31 september 2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.