Prognosis of Signet Ring Cells in Upper Digestive Neoplasms (ADCI001)
| Tracking Information | |||||
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| First Received Date ICMJE | October 26, 2010 | ||||
| Last Updated Date | October 22, 2012 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01249859 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prognosis of Signet Ring Cells in Upper Digestive Neoplasms | ||||
| Official Title ICMJE | Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas? | ||||
| Brief Summary | Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries
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
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. |
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| Detailed Description | stomach cancer signet ring cell carcinoma prognosis chemotherapy |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2500 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01249859 | ||||
| Other Study ID Numbers ICMJE | ADCI001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Christophe MARIETTE, University Hospital, Lille | ||||
| Study Sponsor ICMJE | University Hospital, Lille | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Lille | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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