Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-08 @ 1:59 AM
Study NCT ID:
NCT01220934
Status:
COMPLETED
Last Update Posted:
2018-06-20
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 443}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': '12 months'}, {'measure': 'Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': '12 months'}, {'measure': 'Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Documentation of the testing process for HER2-positive tumors', 'timeFrame': '12 months'}, {'measure': 'Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice', 'timeFrame': '12 months'}, {'measure': 'Documentation of backbone chemotherapy treatment and concomitant medication', 'timeFrame': '12 months'}, {'measure': 'Quality of Life questionnaire', 'timeFrame': '12 months'}, {'measure': 'Surveillance of pain intensity and analgesic consumption', 'timeFrame': '12 months'}, {'measure': 'Surveillance of weight change', 'timeFrame': '12 months'}, {'measure': 'Safety (incidence of adverse events)', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Gastric cancer patients receiving Herceptin in routine clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 years of age\n* Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) with locally advanced and/or metastatic disease\n* HER2-positive tumor\n* Patients who are eligible for treatment with Herceptin according to the judgment of the physician\n\nExclusion Criteria:\n\n* Unwilling or unable to sign informed consent form\n* Any contraindications, interactions and incompatibilities to Herceptin'}, 'identificationModule': {'nctId': 'NCT01220934', 'briefTitle': 'An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)', 'orgStudyIdInfo': {'id': 'ML22834'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60488', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}