Prognosis of Signet Ring Cells in Upper Digestive Neoplasms (ADCI001)
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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? |
- 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 ]
- 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 |
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.
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 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 June 18, 2013