Prognosis of Signet Ring Cells in Upper Digestive Neoplasms (ADCI001)

University Hospital, Lille

Status: Completed

Conditions: Case-control Study; Signet Ring Cell Carcinoma; Prognostic; Stomach Disease; Oesophagus

Study type: Observational

Funder types: Other

Identifiers

NCT01249859

ADCI 001

Details and patient eligibility

About

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.

Full description

stomach cancer signet ring cell carcinoma prognosis chemotherapy

Enrollment: 2,500 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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.

Exclusion criteria

• Histological type other than adenocarcinoma
• Other localization than esogastric junction, esophagus or stomach

Trial design

2,500 participants in 2 patient groups

Signet ring cell carcinoma

non signet ring cell adenocarcinoma