Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-08 @ 6:30 PM
Study NCT ID:
NCT05923567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3yr overall survival', 'timeFrame': 'Survival period from surgery date, 3 years', 'description': '3-year survival rate for patients who underwent surgery for pancreatic cancer'}], 'secondaryOutcomes': [{'measure': '1yr disease free survival', 'timeFrame': 'Period without recurrence from the date of surgery, one year', 'description': 'Recurrence rate in patients who have undergone surgery for pancreatic cancer within a year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Background Carbohydrate antigen 19-9 (CA19-9) is used as a marker to predict recurrence and survival of patients with Pancreatic cancer(PDAC). Recently, fecal elastase-1(FE-1), a marker of pancreatic exocrine function, has been shown to correlate with prognosis in patients with PDAC. However, there have been no studies that have predicted prognosis by combining these two factors. In this study, investigators developed a predictive strategy for prognosis of PDAC using data on preoperative CA19-9 and FE-1 levels.6\n\nMethods The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The clinical data of patients with resectable pancreatic cancer from two hospitals were analyzed. The cut-off points of preoperative CA19-9 and FE-1 levels were extracted from the Youden index and previous studies (385 U/ml and 100 µg/g stool, respectively). Cox proportional hazard models were used to investigate the association between preoperative tumor marker levels and survival (3-overall survival and 1-year recurrence free survival) after surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Investigators conducted a retrospective study using data from 857 patients with pancreatic cancer enrolled in two hospitals in the Republic of Korea (179 from Gangnam Severance Hospital and 678 from Seoul National University Hospital) from January 5, 2010 to December 31, 2019.\n\nExclusion Criteria:\n\n* Investigators excluded patients without information about preoperative tumor marker levels (n = 45), those who received neoadjuvant (n = 169), those with preoperative CA19-9 levels \\< 9.0 \\[Lewis antibody-negative patients\\] (n = 98), those with missing covariates (n = 3) and R2 resection (n = 6).'}, 'identificationModule': {'nctId': 'NCT05923567', 'briefTitle': 'New Predictive Marker for Pancreatic Cancer Using CA19-9 and Fecal Elastase', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Novel Predictive Strategy Using CA19-9 and Fecal Elastase Levels to Make Treatment Decisions for Resectable Pancreatic Cancer; Retrospective Study', 'orgStudyIdInfo': {'id': '3-2020-0522'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CA19-9<385 & FE-1>100'}, {'label': 'CA19-9<385 and FE-1>100'}, {'label': 'CA19-9>385 & FE-1>100'}, {'label': 'CA19-9>385 & FE-1<100'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoiciate Professor', 'investigatorFullName': 'Hyung Sun Kim', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}