Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-29 @ 10:57 AM
Study NCT ID:
NCT05941104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-12
First Post:
2023-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-09', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-07-09', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Surviving up to 2 years', 'timeFrame': 'From date of hospitalization until the date of death from any cause, assessed up to 2 years.'}], 'primaryOutcomes': [{'measure': 'Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)', 'timeFrame': 'baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.', 'description': 'Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach α coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)', 'timeFrame': 'baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms', 'Frailty', 'Blood Biological Indicators', 'Quality of Life', 'Survival']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.\n\nThe main questions it aims to answer are:\n\n1. Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.\n2. Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.\n\nParticipants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prostate cancer patients with Radical Prostatectomy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);\n2. Radical prostatectomy is planned;\n3. Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Diagnosed with other malignant tumors at the same time;\n2. Patients with acute infection.'}, 'identificationModule': {'nctId': 'NCT05941104', 'briefTitle': 'The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Anhui Provincial Hospital'}, 'officialTitle': 'The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'ShanShan Liu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Frail group', 'interventionNames': ['Other: frailty']}, {'label': 'Non-frail group'}], 'interventions': [{'name': 'frailty', 'type': 'OTHER', 'description': 'Frailty is a group of common clinical syndromes in the elderly, characterized by systematic, dynamic and reversible, the core of which is the decline of physiological reserves and the destruction of self-balance.', 'armGroupLabels': ['Frail group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}