Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT03098758
Status:
UNKNOWN
Last Update Posted:
2019-07-24
First Post:
2017-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Analysis in Peritoneal Washing Citology for Locally Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'gastric cancer cells in peritoneal washing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'specific markers in peritoneal cells', 'timeFrame': 'during surgical intervention', 'description': 'Detection of CK20, CEA and BER-EP4 by PCR technique in peritoneal washing of advanced gastric cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polymerase Chain Reaction', 'gastric cancer', 'citology', 'peritoneal washing', 'CK20', 'CEA', 'BER-EP4'], 'conditions': ['Gastric Cancer', 'Polymerase Chain Reaction']}, 'descriptionModule': {'briefSummary': 'Gastric carcinoma is a disease with a high mortality. Peritoneal washing cytology has a recognized prognostic utility. However sensibility of this study is not appropriate. Studies with PCR (polymerase chain retrotranscription) can increase sensibility and accurate staging information.\n\nObjective: To analyze the sensibility and specificity of the expression of CK20, CEA and Ber-EP4 with PCR technique in peritoneal washings of advanced gastric carcinoma without clinical evidence of peritoneal carcinomatosis.\n\nMethodology: Retrotranscription analysis (RT-PCR) and quantitative PCR (qPCR) of CK20, CEA and Ber-EP4 in peritoneal washing. Test the feasibility of qPCR with this new marker (Ber-EP4). Comparison of the results with data obtained with conventional cytology. Study of peritoneal recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced gastric cancer without macroscopic peritoneal carcinomatosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with resectable advanced gastric cancer\n* Informed consent\n\nExclusion Criteria:\n\n* Macroscopic peritoneal carcinomatosis\n* Non operable patients'}, 'identificationModule': {'nctId': 'NCT03098758', 'briefTitle': 'Molecular Analysis in Peritoneal Washing Citology for Locally Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Pilot Study of Comparative Molecular Analysis CK20, CEA and BER-EP4 in Peritoneal Washing Citology for Locally Advanced Gastric Cancer and Their Ability to Predict Peritoneal Dissemination', 'orgStudyIdInfo': {'id': 'CIRPT_AL2017_1'}}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Parc Tauli Hospital Universitari', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Alexis Luna, MD PhD', 'role': 'CONTACT', 'email': 'Aluna@tauli.cat', 'phone': '0034937231010', 'phoneExt': '21458'}], 'overallOfficials': [{'name': 'Alexis Luna, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporación Parc Taulí'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Alexis Luna', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}