Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-28 @ 11:50 PM
Study NCT ID:
NCT06316466
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001054', 'term': 'Apolipoproteins A'}], 'ancestors': [{'id': 'D001053', 'term': 'Apolipoproteins'}, {'id': 'D008074', 'term': 'Lipoproteins'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001059', 'term': 'Apoproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS', 'timeFrame': '1-30months', 'description': 'The primary endpoint was overall survival (OS), defined as the time from pathological diagnosis to either death or the most recent follow-up.'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '1-10months', 'description': 'The secondary measure was the duration from the initial diagnosis to disease progression, referred to as progression-free survival (PFS). Both are measured in months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic carcinoma; Lipoprotein a; Overall survival; Prognosis'], 'conditions': ['Pancreatic Carcinoma; Lipoprotein a; Overall Survival; Prognosis']}, 'descriptionModule': {'briefSummary': 'Background: This study aims to assess the prognostic significance of serum lipoprotein (a) \\[Lp (a)\\] levels on overall survival (OS) and progression free survival (PFS) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (PSM).\n\nMethods: A retrospective analysis was conducted on the clinicopathological data of 364 patients diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022. The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. We applied PSM analysis to minimize selection bias. The study compared OS and PFS between two groups by Kaplan-Meier method and analyzed differences using the log-rank test. Additionally, univariate and multivariate Cox-regression analyses were performed to identify prognostic factors among patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This research involved the inclusion of 364 individuals who were diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022, following pathological confirmation. The criteria for inclusion were as follows: (1) Adult patients aged over 18 years; (2) Patients with histologically confirmed pancreatic cancer through surgical or puncture procedures; (3) Complete lipid profiles available within one week prior to diagnosis. Exclusion criteria were as follows: (1) Presence of concurrent malignancies; (2) History of previous treatments such as pancreatectomy, chemotherapy, or radiation therapy; (3) Incomplete clinicopathological information.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged over 18 years; (2) Patients with histologically confirmed pancreatic cancer through surgical or puncture procedures; (3) Complete lipid profiles available within one week prior to diagnosis.\n\nExclusion Criteria:\n\n* (1) Presence of concurrent malignancies; (2) History of previous treatments such as pancreatectomy, chemotherapy, or radiation therapy; (3) Incomplete clinicopathological information.'}, 'identificationModule': {'nctId': 'NCT06316466', 'briefTitle': 'Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis', 'orgStudyIdInfo': {'id': 'QYFYWZLL28521'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the high Lp (a) groups and the low Lp (a) groups', 'description': 'The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups.', 'interventionNames': ['Other: Lp(a)']}, {'label': 'the low Lp (a) groups', 'description': 'The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups.', 'interventionNames': ['Other: Lp(a)']}], 'interventions': [{'name': 'Lp(a)', 'type': 'OTHER', 'description': 'The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups.', 'armGroupLabels': ['the high Lp (a) groups and the low Lp (a) groups', 'the low Lp (a) groups']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinyue Liu', 'role': 'CONTACT', 'email': 'liujinyue99@163.com', 'phone': '17854269227'}], 'facility': 'Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Jinyue liu', 'role': 'CONTACT', 'email': 'liujinyue99@163.com', 'phone': '17854269227'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'jingxue', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'jingxue', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}