Prognosis of Signet Ring Cells in Upper Digestive Neoplasms
NCT ID: NCT01249859
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2500 participants
OBSERVATIONAL
2010-03-31
2010-12-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Signet ring cell carcinoma
No interventions assigned to this group
non signet ring cell adenocarcinoma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Other localization than esogastric junction, esophagus or stomach
18 Years
95 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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christophe mariette, MD, PhD
Role: STUDY_DIRECTOR
CHU lille
Locations
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University Hospital of Lille
Lille, , France
Countries
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References
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Robb WB, Messager M, Goere D, Pichot-Delahaye V, Lefevre JH, Louis D, Guiramand J, Kraft K, Mariette C; FREGATWorking Group-FRENCH. Predictive factors of postoperative mortality after junctional and gastric adenocarcinoma resection. JAMA Surg. 2013 Jul;148(7):624-31. doi: 10.1001/jamasurg.2013.63.
Messager M, Lefevre JH, Pichot-Delahaye V, Souadka A, Piessen G, Mariette C; FREGAT working group - FRENCH. The impact of perioperative chemotherapy on survival in patients with gastric signet ring cell adenocarcinoma: a multicenter comparative study. Ann Surg. 2011 Nov;254(5):684-93; discussion 693. doi: 10.1097/SLA.0b013e3182352647.
Other Identifiers
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ADCI 001
Identifier Type: -
Identifier Source: org_study_id