Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT01905969
Status:
UNKNOWN
Last Update Posted:
2015-03-25
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy
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': 'Archived paraffin blocks'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse free survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric caner, adjuvant chemotherapy'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '22905237', 'type': 'BACKGROUND', 'citation': 'Ishida K, Nishizuka SS, Chiba T, Ikeda M, Kume K, Endo F, Katagiri H, Matsuo T, Noda H, Iwaya T, Yamada N, Fujiwara H, Takahashi M, Itabashi T, Uesugi N, Maesawa C, Tamura G, Sugai T, Otsuka K, Koeda K, Wakabayashi G. Molecular marker identification for relapse prediction in 5-FU-based adjuvant chemotherapy in gastric and colorectal cancers. PLoS One. 2012;7(8):e43236. doi: 10.1371/journal.pone.0043236. Epub 2012 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has improved disease free time and survival. However, there are still considerable number of patients experience relapse even after adjuvant chemotherapy. In an attempt to select patients who really benefit the postoperative adjuvant chemotherapy, we have identified potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by immunohistochemical validation. In the present study, we further validate the significance of the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be determined immediately after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a retrospective study. Data analyses are based on archived record and materials of gastric cancer patients whose treatment was curative surgery followed by adjuvant chemotherapy with S-1.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed gastric cancer.\n* Operated before November 2009.\n* Stage Ib/II(except for T1, T3N0)/III.\n* Received postoperative (R0) adjuvant chemotherapy (S-1).\n* Not received postoperative (R0) adjuvant chemotherapy (surgery alone).\n* Signed informed consent to provide paraffin embedded tissue of removed specimens.\n\nExclusion Criteria:\n\n* With advanced neoplastic lesions other than gastric cancer.\n* Paraffin embedded tissue is not available.\n* Unknown S-1 treatment condition.'}, 'identificationModule': {'nctId': 'NCT01905969', 'acronym': 'NJBMR', 'briefTitle': 'Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Iwate Medical University'}, 'officialTitle': 'Retrospective Validation for Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy With S-1', 'orgStudyIdInfo': {'id': 'MIAST-NJBMR-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biomarker positive', 'description': 'NF-kB(+)/JNK(-) in curatively removed specimens'}, {'label': 'Biomarker negative', 'description': 'NF-kB(-)/JNK(+) in curatively removed specimens'}]}, 'contactsLocationsModule': {'locations': [{'zip': '020-8505', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Medical University School of Medicine', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iwate Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Satoshi Nishizuka', 'investigatorAffiliation': 'Iwate Medical University'}}}}