Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-27 @ 12:59 AM
Study NCT ID:
NCT02482259
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Frailty in Patients With Advanced Hepatocellular Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life - EORTC QCQ 30 and HCC18', 'timeFrame': 'Baseline, week 9 and week 18'}, {'measure': 'Biomarker assessment of frailty and associated factors', 'timeFrame': 'Baseline, week 9 and week 18'}], 'primaryOutcomes': [{'measure': 'Percentage patients consenting for assessment out of number of patients approached', 'timeFrame': 'baseline', 'description': 'Number of patients consenting for the study as a percentage of the number of patients approached about the study'}, {'measure': 'Time taken to complete assessments', 'timeFrame': 'Baseline, week 9 and week 18', 'description': 'Time taken to completed assessments recorded by clinical trials officer'}], 'secondaryOutcomes': [{'measure': 'Frailty as a predictor of grade 3/4 toxicity', 'timeFrame': 'Baseline, week 9 and week 18', 'description': 'Frailty score at baseline and during study time predict for outcome'}, {'measure': 'Muscle mass and timed get up and go as predictors of outcome', 'timeFrame': 'Baseline, week 9 and week 18', 'description': 'muscle mass as measured on routine CT scans and get up and go as measured in frailty score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Cancer']}, 'descriptionModule': {'briefSummary': 'This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.', 'detailedDescription': 'This study is primarily looking to see if it is feasible to assess frailty in patients with advanced hepatocellular cancer. It is also evaluating whether there may be any correlation between these assessments and toxicity of treatment and outcome.\n\nThe assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed measuring muscle mass from imaging performed as part of routine clinical care.\n\nThe assessments will be performed at baseline on entry into the study, at week 9 and week 18.\n\nThere is the option for patients to also donate a blood samples for research purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Hepatocellular cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of hepatocellular cancer not suitable for curative treatment\n* Seen by an oncologist or hepatologist for consideration of palliative treatment and a decision regarding management already made\n* WHO Performance status 0-2\n* Childs Pugh Score A or B\n* Written informed consent\n\nExclusion Criteria:\n\nN/A\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02482259', 'acronym': 'FAC-L', 'briefTitle': 'Assessment of Frailty in Patients With Advanced Hepatocellular Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Newcastle-upon-Tyne Hospitals NHS Trust'}, 'officialTitle': 'Assessment of Frailty in Patients With Advanced Hepatocellular Cancers', 'orgStudyIdInfo': {'id': '6730'}}, 'contactsLocationsModule': {'locations': [{'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Elizabeth R Plummer, MD, MRCP, BA, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newcastle Unversity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newcastle-upon-Tyne Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}