Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT05802394
Status:
RECRUITING
Last Update Posted:
2023-04-12
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2030-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The prognostic value of MRD', 'timeFrame': 'Baseline until PD or death, whichever occurs first (up to approximately 24 months)', 'description': 'The prognostic value of baseline MRD and dynamic MRD changes'}, {'measure': 'The prognostic role of targeted therapy selected based on MRD', 'timeFrame': 'Baseline until PD or death, whichever occurs first (up to approximately 24 months)', 'description': 'The prognostic role of targeted therapy selected based on MRD'}], 'primaryOutcomes': [{'measure': 'Resection rate', 'timeFrame': 'Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)', 'description': 'Proportion of patients who receive surgical resection'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Baseline until PD or death, whichever occurs first (up to approximately 24 months)', 'description': 'The date of conversion therapy initiation to death due to any cause.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Baseline until PD or death, whichever occurs first (up to approximately 24 months)', 'description': 'The date of conversion therapy initiation to tumor progression or death due to any cause in the absence of progression.'}, {'measure': 'R0 resection rate', 'timeFrame': 'Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)', 'description': 'Proportion of patients who receive R0 surgical resection'}, {'measure': 'Major pathological response', 'timeFrame': 'Baseline until operation, PD or death, whichever occurs first (up to approximately 24 months)', 'description': '≤10% of the viable tumor cell in resected sample'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Locally Advanced']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in borderline resectable or locally advanced pancreatic cancer. The main questions it aims to answer are:\n\n* prognostic value of baseline MRD;\n* the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before conversion therapy initiation and at the first imaging assessment after chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with histologically confirmed borderline resectable or locally advanced pancreatic cancer;\n* conversion therapy was planned;\n* both sexes, age ≥18 years old;\n* ECOG performance status score ≤2;\n* the expected survival time was ≥3 months.\n\nExclusion Criteria:\n\n* a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;\n* treated with any systemic antitumor treatment before first-line chemotherapy onset;\n* died or lost to follow-up within one month after the initiation of first-line chemotherpay;\n* combined with other primary malignances.'}, 'identificationModule': {'nctId': 'NCT05802394', 'acronym': 'MAP-03', 'briefTitle': 'The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Value of Molecular Residual Disease Monitoring Based on ctDNA in Borderline Resectable or Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'K3378-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRD-guided', 'description': 'Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will receive a later-line therapy.', 'interventionNames': ['Drug: Later-line therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Routine treatment', 'description': 'Patients with elevated MRD from baseline at the first imaging assessment but without radiographic progressive disease will continued their current therapy.'}], 'interventions': [{'name': 'Later-line therapy', 'type': 'DRUG', 'description': 'Another chemotherapy regimen, targeted therapy, or immunotherapy', 'armGroupLabels': ['MRD-guided']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunmei Bai, M.D.', 'role': 'CONTACT', 'email': 'tangh160706@163.com', 'phone': '010-69168764'}], 'facility': 'Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Chunmei Bai, MD', 'role': 'CONTACT', 'email': 'tangh160706@163.com', 'phone': '010-69158764', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Chunmei Bai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}