Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-26 @ 9:58 PM
Study NCT ID:
NCT01824966
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2013-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-04', 'studyFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer specific 5 year survival in SRCC', 'timeFrame': 'from surgery', 'description': 'Cancer specific 5 year survival classified into two groups according to WHO criteria (\\>50% SRC or \\<50% SRC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Esophagectomy', 'Signet Ring Cells'], 'conditions': ['Adenocarcinoma', 'Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'There has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).', 'detailedDescription': 'Adenocarcinoma (ADC) of the esophagus and gastroesophageal junction (GEJ) is an aggressive neoplasm and has a poor prognosis. Surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma.\n\nSignet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (SRC)). According to the World Health Organisation (WHO), a true signet-ring cell carcinoma (SRCca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of SRC in the stroma. If the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (ADC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From our prospectively built database we retrieved all adenocarcinoma from 1990 till 2009 who underwent primary surgery with R0 resection. Seven hundred seventy-nine patients were included for further analysis. Pathology reports mentioning signet ring cells (n = 82) were reviewed by our pathologist and, after confirmation, tumors were classified into two groups according to WHO criteria (\\>50% SRC or \\<50% SRC). The remaining 697 ADC patients served as control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adenocarcinoma R0 resection Primary surgery\n\nExclusion Criteria:\n\n\\- Other histology R1 or R2 resection Neoadjuvant therapy'}, 'identificationModule': {'nctId': 'NCT01824966', 'acronym': 'SRCC', 'briefTitle': 'Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gasthuisberg'}, 'officialTitle': 'Signet Ring Cells in Esophageal and GE Junction Carcinomas Have a More Aggressive Biological Behavior', 'orgStudyIdInfo': {'id': 'SRCC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SRC<50%', 'description': 'Adenocarcinoma containing \\< 50% of signet ring cells'}, {'label': 'SRC>50%', 'description': 'Adenocarcinoma containing \\> 50% of signet ring cells'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven; Dept. of Thoracic Surgery', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Philippe Nafteux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Leuven; Dept. of Thoracic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gasthuisberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, MSc, Datamanager', 'investigatorFullName': 'Johnny Moons', 'investigatorAffiliation': 'University Hospital, Gasthuisberg'}}}}