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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christophe MARIETTE, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01249859
First received: October 26, 2010
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

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 [ Time Frame: participants are followed until death or time point at 31 september 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3 year recurrence free survival [ Time Frame: participants are followed until recurrence or time point at 31 september 2010 ] [ Designated as safety issue: No ]
  • Overall 3 year survival according to tumor stage, node invasion, and tumor localization [ Time Frame: participants are followed until death or time point at 31 september 2010 ] [ Designated as safety issue: No ]

Enrollment: 2500
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Signet ring cell carcinoma
non signet ring cell adenocarcinoma

Detailed Description:

stomach cancer signet ring cell carcinoma prognosis chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Intention to treat retrospective case control multicentric study, Patients will be divided into two groups (ADCI or ADNCI) depending on the presence or not of signet ring cells on definitive histologic analysis Another analysis based on chemo administration or not will be provided A pairing on demographic criteria (age, sex, ASA score, center, TNM stage and will be done to ensure comparability in case control study groups.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01249859

Locations
France
University Hospital of Lille
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Director: christophe mariette, MD, PhD CHU lille
  More Information

No publications provided by University Hospital, Lille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe MARIETTE, MD, PhD, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01249859     History of Changes
Other Study ID Numbers: ADCI001
Study First Received: October 26, 2010
Last Updated: October 22, 2012
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by University Hospital, Lille:
stomach disease
signet ring cell carcinoma
chemotherapy
Prognostic

Additional relevant MeSH terms:
Carcinoma
Stomach Diseases
Carcinoma, Signet Ring Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous

ClinicalTrials.gov processed this record on July 24, 2014