Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-04 @ 2:44 PM
Study NCT ID:
NCT05483257
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2022-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Subtyping for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059014', 'term': 'High-Throughput Nucleotide Sequencing'}], 'ancestors': [{'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Matched blood cells and tumor tissues'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-31', 'studyFirstSubmitDate': '2022-07-29', 'studyFirstSubmitQcDate': '2022-07-31', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': '2 years', 'description': 'Comparison of DFS between patients with specific HLA-I genotypes or not'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human leukocyte antigen class I', 'supertypes', 'recurrence'], 'conditions': ['Pancreatic Cancer Resectable']}, 'referencesModule': {'references': [{'pmid': '37026827', 'type': 'DERIVED', 'citation': 'Wen C, Zhang L, Yang Y, Jin Y, Ren D, Zhang Z, Zou S, Li F, Sun H, Jin J, Lu X, Xie J, Cheng D, Xu Z, Chen H, Mao B, Zhang J, Wang J, Deng X, Peng C, Li H, Jiang C, Lin L, Zhang H, Chen H, Shen B, Zhan Q. Specific human leukocyte antigen class I genotypes predict prognosis in resected pancreatic adenocarcinoma: a retrospective cohort study. Int J Surg. 2023 Jul 1;109(7):1941-1952. doi: 10.1097/JS9.0000000000000264.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic adenocarcinoma (PAAD) patients following surgeries are prone to relapse shortly, while it is not well understood by current biomarkers. Given the potential associations of human leukocyte antigen class I (HLA-I) genotype with oncogenic mutational profile and immunotherapy efficacy, we aimed to assess whether differential HLA-I genotype could predict the postoperative outcomes in resected PAAD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '34 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Radically resected patients with pancreatic adenocarcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radically resected pancreatic adenocarcinoma (stage I-III)\n* Resected tumor tissues and matched blood cells available\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pancreatic cancer except pancreatic adenocarcinoma\n* Non-radical resection'}, 'identificationModule': {'nctId': 'NCT05483257', 'briefTitle': 'Molecular Subtyping for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Molecular Subtyping Based on Specific HLA-I Genotypes for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma: A Retrospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'M-Cli200633-PC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Multigene panel for next-generation sequencing', 'type': 'DEVICE', 'description': 'HLA-I genotyping based on next-generation sequencing for prognosis evaluation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BAIYONG SHEN', 'class': 'OTHER'}, 'collaborators': [{'name': 'GeneCast Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'BAIYONG SHEN', 'investigatorAffiliation': 'Ruijin Hospital'}}}}