Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-13 @ 1:17 PM
Study NCT ID:
NCT04782557
Status:
RECRUITING
Last Update Posted:
2021-03-04
First Post:
2021-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS Guided HVA and PVA for Circulating Tumor DNA in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood', 'timeFrame': '3 months', 'description': 'Plasma DNA will be extracted using the QIAamp Circulating Nucleic Acid Kit (Qiagen), and the concentration of the circulating tumor DNA will be reported in variant allelic fraction (expressed in %)'}], 'secondaryOutcomes': [{'measure': 'Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA', 'timeFrame': '3 months', 'description': 'If ctDNA is identified, further genomic and proteomic analysis will be performed. It will be measured in terms variant allelic fraction (expressed in %)'}, {'measure': 'Staging of the GI cancer', 'timeFrame': '3 months', 'description': 'The pathological TNM staging of the resected specimen will be recorded.'}, {'measure': 'Recurrence', 'timeFrame': '5 years', 'description': 'any recurrence of the tumor will be recorded'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'overall survival will be recorded'}, {'measure': 'Progression-free survival', 'timeFrame': '5 years', 'description': 'progression free survival will be recorded'}, {'measure': 'Technical success rate of EUS-PVA and HVA', 'timeFrame': '1 day', 'description': 'The technical success rate of the EUS guided procedure will be recorded. Reasons for failure of the cases will be recorded.'}, {'measure': 'Adverse events of EUS-PVA and HVA', 'timeFrame': '30 days', 'description': 'the adverse events of the EUS procedure will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating Tumor Cell', 'Gastrointestinal Cancer', 'Endoscopic ultrasound portal vein aspiration'], 'conditions': ['Circulating Tumor Cell', 'Gastrointestinal Cancer']}, 'descriptionModule': {'briefSummary': 'The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.', 'detailedDescription': 'The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age \\>= 18 years old\n2. Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer\n3. Undergoing treatment with either:\n\n 1. Surgery\n 2. Neoadjuvant chemotherapy\n 3. Neoadjuvant chemoirradiation\n 4. Palliative chemotherapy/ immunotherapy\n\n Exclusion criteria:\n\n <!-- -->\n\n 1. Synchronous cancer of other sites\n 2. Cardia, high lesser curve tumors, oesophagogastric junction tumors\n 3. Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein\n 4. Patients with coagulopathy (international normalized ratio \\>1.3, partial thromboplastin time greater than twice that of control), platelet count \\<50,000x103/uL\n 5. Patients unwilling to undergo follow-up assessments\n 6. Patients with liver cirrhosis, portal hypertension and/ or gastric varices\n 7. Patient refusal to participate\n\n \\-'}, 'identificationModule': {'nctId': 'NCT04782557', 'briefTitle': 'EUS Guided HVA and PVA for Circulating Tumor DNA in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers', 'orgStudyIdInfo': {'id': '2020.321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EUS-guided PVA and HVA', 'description': 'Patient will undergo EUS-guided PVA and HVA', 'interventionNames': ['Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration']}], 'interventions': [{'name': 'EUS-guided portal vein and hepatic vein aspiration', 'type': 'DIAGNOSTIC_TEST', 'description': 'EUS-guided portal vein and hepatic vein aspiration', 'armGroupLabels': ['EUS-guided PVA and HVA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shannon Chan, FRCSEd', 'role': 'CONTACT', 'email': 'shannonchan@surgery.cuhk.edu.hk', 'phone': '852-35052627'}], 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Shannon Chan, FRCSEd', 'role': 'CONTACT', 'email': 'shannonchan@surgery.cuhk.edu.hk', 'phone': '852-35052627'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'CHAN SHANNON MELISSA', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}