Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05802420
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-02-01', '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': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The prognostic value of MRD', 'timeFrame': 'Baseline until death from any cause (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 death from any cause (up to approximately 24 months)', 'description': 'The prognostic role of targeted therapy selected based on MRD'}], 'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Baseline until death from any cause (up to approximately 24 months)', 'description': 'The date of first-line chemotherpay initiation to tumor progression or death due to any cause in the absence of progression.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Baseline until death from any cause (up to approximately 24 months)', 'description': 'The date of first-line chemotherpay initiation to death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Advanced Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in advanced or metastatic 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 first-line chemotherapy 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 unresectable advanced or metastatic pancreatic cancer;\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': 'NCT05802420', 'acronym': 'MAP-01', 'briefTitle': 'The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Value of Molecular Residual Disease Monitoring Based on ctDNA in Advanced or Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'K3378-01'}}, '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': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunmei Bai, MD', 'role': 'CONTACT', 'email': 'tangh160706@163.com', 'phone': '010-69168764'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Chunmei Bai, MD', 'role': 'CONTACT', 'email': 'tangh160706@163.com', 'phone': '010-69158764', 'phoneExt': '+86'}, {'name': 'Hui Tang, MD', 'role': 'CONTACT', 'email': 'tangh160706@163.com', 'phone': '010-69158761', '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'}}}}