Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04241367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2020-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical applicability of KRAS mutations', 'timeFrame': 'Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months', 'description': 'Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.'}, {'measure': 'Discovery of biomarkers through ctDNA panel', 'timeFrame': 'Locally advanced and Resectable patients: Pre Treatment, 1,2,3,6,9,12,15,18,21,24months/ Metastatic patients: Pre Treatment, 1,2,4,6,8,10,12,14,16,18,20,22,24 months', 'description': 'Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreas Adenocarcinoma', 'Circulating-tumor DNA', 'KRAS mutations', 'Cancer Panel', 'Prognostic markers'], 'conditions': ['Pancreas Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '40509918', 'type': 'DERIVED', 'citation': 'Chun JW, Lee DE, Kim MK, Hwang JH, Lee SH, Jung MK, Kim EJ, Ahn DW, Kim YH, Han SS, Park SJ, Lee WJ, Woo SM, Kong SY. Optimal Value of Mutant KRAS Circulating Tumor DNA for Predicting Prognosis and Monitoring in Patients with Pancreatic Adenocarcinoma: A Prospective Multicenter Cohort Study. Clin Chem. 2025 Sep 3;71(9):993-1004. doi: 10.1093/clinchem/hvaf066.'}]}, 'descriptionModule': {'briefSummary': 'This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.', 'detailedDescription': 'Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.\n\n* Quantification and monitoring of KRAS mutations Using droplet digital PCR in ctDNA extracted from collected patient samples.\n* Correlation analysis of KRAS mutation results with clinical data.\n\nDiscovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.\n\n* Gene panel composition for pancreatic cancer therapeutic target determination and monitoring.\n* A panel was performed using gDNA and ctDNA of tumor tissue collected from pancreatic cancer patients.\n* Comparative analysis of panel results and quantitative KRAS mutations and evaluation of clinical applicability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatient or outpatient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pathologically confirmed pancreatic adenocarcinoma.\n\nExclusion Criteria:\n\n* Patients disagree with the study.'}, 'identificationModule': {'nctId': 'NCT04241367', 'briefTitle': 'Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy', 'orgStudyIdInfo': {'id': 'NCC2019-0027'}}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Sangmyung Woo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Senior Scientist', 'investigatorFullName': 'Sang Myung Woo', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}