Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05893667
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2023-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Inflammatory Markers in LARC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-29', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival Disease-free survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Pathological response through Ryan Tumor Regression Grade', 'timeFrame': 'at study completion, average of 5 years', 'description': 'TRG 1-5; 1- no viable cancer cells; 5- no fibrosis, with extensive residual disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis.\n\nMethods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'as in inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery\n\nExclusion Criteria:\n\n* evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders'}, 'identificationModule': {'nctId': 'NCT05893667', 'briefTitle': 'Evaluation of Inflammatory Markers in LARC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Pedro Hispano'}, 'officialTitle': 'Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients', 'orgStudyIdInfo': {'id': 'HPedroHispano'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High levels of inflammatory scores', 'interventionNames': ['Diagnostic Test: Inflammatory markers']}, {'label': 'Low levels of inflammatory scores', 'interventionNames': ['Diagnostic Test: Inflammatory markers']}], 'interventions': [{'name': 'Inflammatory markers', 'type': 'DIAGNOSTIC_TEST', 'description': 'analysis of inflammatory scores', 'armGroupLabels': ['High levels of inflammatory scores', 'Low levels of inflammatory scores']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Pedro Hispano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marina Morais', 'investigatorAffiliation': 'Hospital Pedro Hispano'}}}}