Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 8:18 AM
Study NCT ID:
NCT04520295
Status:
UNKNOWN
Last Update Posted:
2020-08-20
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ctDNA Screening in Advanced HER2 Positive Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in molecular biomarkers at time on best overall response', 'timeFrame': '36 months', 'description': 'Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in molecular biomarkers at time on disease progression', 'timeFrame': '36 months', 'description': 'Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2-positive Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.', 'detailedDescription': 'Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HER2 positive gastric cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male/female patients aged over 18 years.\n2. Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.\n3. HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive, HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.\n4. At least one measurable lesion should be confirmed by imaging examination.\n5. Eligible peripheral blood samples\n6. Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy.\n7. For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil.\n8. For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients.\n9. Willing to provide clinicopathological information and imaging information.\n\nExclusion Criteria:\n\n1. Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.\n2. With second primary malignant diseases.\n3. Other situations assessed by investigator can disturb quality control of the investigation.'}, 'identificationModule': {'nctId': 'NCT04520295', 'briefTitle': 'ctDNA Screening in Advanced HER2 Positive Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy', 'orgStudyIdInfo': {'id': 'BSctDNA-GC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2 positive cohort', 'interventionNames': ['Genetic: ctDNA screening']}], 'interventions': [{'name': 'ctDNA screening', 'type': 'GENETIC', 'description': 'Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.', 'armGroupLabels': ['HER2 positive cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Zhang, MD & Ph. D', 'role': 'CONTACT', 'email': 'junzhang10977@sjtu.edu.cn', 'phone': '+86-13818332497'}, {'name': 'Jun Zhang, MD & Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Oncology, Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jing Liu', 'role': 'CONTACT', 'email': 'liujing23@vip.163.com', 'phone': '+86-18001753364'}, {'name': 'Chenfei Zhou', 'role': 'CONTACT', 'email': 'raining_grayday@hotmail.com', 'phone': '+86-13761618390'}], 'overallOfficials': [{'name': 'Jun Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Department of Oncology', 'investigatorFullName': 'Jun Zhang', 'investigatorAffiliation': 'Ruijin Hospital'}}}}