Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-30 @ 7:39 AM
Study NCT ID:
NCT01249859
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2010-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Signet Ring Cells in Upper Digestive Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018279', 'term': 'Carcinoma, Signet Ring Cell'}, {'id': 'D013272', 'term': 'Stomach Diseases'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2010-10-26', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'participants are followed until death or time point at 31 september 2010'}], 'secondaryOutcomes': [{'measure': '3 year recurrence free survival', 'timeFrame': 'participants are followed until recurrence or time point at 31 september 2010'}, {'measure': 'Overall 3 year survival according to tumor stage, node invasion, and tumor localization', 'timeFrame': 'participants are followed until death or time point at 31 september 2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stomach disease', 'signet ring cell carcinoma', 'chemotherapy', 'Prognostic'], 'conditions': ['Signet Ring Cell Carcinoma', 'Stomach Disease', 'Oesophagus', 'Prognostic', 'Case-control Study']}, 'referencesModule': {'references': [{'pmid': '23552982', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '22005144', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries\n\n* Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.\n* 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.\n\nPrimary 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\n\nSecondary objectives\n\n* Impact of neoadjuvant CT on overall survival\n* Impact and differential diagnostic value of linitis\n* R0 resection rates\n* 3 years recurrence free survival\n* Overall 3 years survival\n* Prognostic factors\n* Prognostic value of the presence of a minority quota of signet ring cell\n* Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients\n* Tolerance of (radio) chemotherapy for ADCI\n\nMethodology 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.\n\nInclusion 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.\n\nFor whom the first consultation took place between January 1997 and January 2010\n\nExclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach\n\nPlanned study period The data will be collected over a period from January 1997 to January 2010.\n\nThe objective is to complete the data collection for summer 2010.', 'detailedDescription': 'stomach cancer signet ring cell carcinoma prognosis chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* For whom the first consultation took place between January 1997 and January 2010\n* As they benefit from a medical and/or surgical support (primitive cancer being or not resected), whatever the metastatic or the recurrence situation was.\n\nExclusion Criteria:\n\n* Histological type other than adenocarcinoma\n* Other localization than esogastric junction, esophagus or stomach'}, 'identificationModule': {'nctId': 'NCT01249859', 'acronym': 'ADCI001', 'briefTitle': 'Prognosis of Signet Ring Cells in Upper Digestive Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?', 'orgStudyIdInfo': {'id': 'ADCI 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Signet ring cell carcinoma'}, {'label': 'non signet ring cell adenocarcinoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'christophe mariette, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}