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

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ClinicalTrials.gov Identifier: NCT01249859
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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

Detailed Description:
stomach cancer signet ring cell carcinoma prognosis chemotherapy

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 : March 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Group/Cohort
Signet ring cell carcinoma
non signet ring cell adenocarcinoma



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 3 year recurrence free survival [ Time Frame: participants are followed until recurrence or time point at 31 september 2010 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01249859     History of Changes
Other Study ID Numbers: ADCI 001
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

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

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