Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-02-11 @ 12:47 AM
Study NCT ID:
NCT03967457
Status:
UNKNOWN
Last Update Posted:
2019-06-20
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Study on the Quality of Life in Cervical Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood samples for the testing of ovarian reserve function'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores from EORTC QLQ-C30', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.', 'description': 'Scores calculated from European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30'}, {'measure': 'Scores from EORTC QLQ-CX24', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.', 'description': 'Scores calculated from EORTC QLQ-CX24'}], 'secondaryOutcomes': [{'measure': 'Concentration of follicle-stimulating hormone', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Follicle-stimulating hormone tested in peripheral blood'}, {'measure': 'Concentration of estradiol', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Estradiol tested in peripheral blood'}, {'measure': 'Concentration of anti-mullerian hormone', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Anti-mullerian hormone tested in peripheral blood'}, {'measure': 'Concentration of inhibin B', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Inhibin B tested in peripheral blood'}, {'measure': 'Bladder capacity at the first void sense', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Bladder capacity at the first void sense tested by urodynamic testing'}, {'measure': 'Bladder capacity at normal desire to void', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Bladder capacity at normal desire to void tested by urodynamic testing'}, {'measure': 'Bladder capacity at strong desire to void', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Bladder capacity at strong desire to void tested by urodynamic testing'}, {'measure': 'Maximun flow rate', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Maximun flow rate tested by urodynamic testing'}, {'measure': 'Average flow rate', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Average flow rate tested by urodynamic testing'}, {'measure': 'Bladder pressure at maximun flow rate', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Bladder pressure at maximun flow rate tested by urodynamic testing'}, {'measure': 'Detrusor pressure at maximun flow rate', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Detrusor pressure at maximun flow rate tested by urodynamic testing'}, {'measure': 'Bladder compliance at strong desire to void', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Bladder compliance at strong desire to void tested by urodynamic testing'}, {'measure': 'Detrusor compliance at strong desire to void', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Detrusor compliance at strong desire to void tested by urodynamic testing'}, {'measure': 'Residual urine volume', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Residual urine volume tested by urodynamic testing'}, {'measure': 'Anal sphincter pressure', 'timeFrame': 'Change from the baseline of four weeks before major therapy at following-up', 'description': 'Anal sphincter pressure tested by rectum dynamic testing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life', 'Cervical Cancer', 'Urodynamics', 'Rectum Dynamics', 'Sex Dysfunction', 'Pelvic Floor Disorders', 'Ovarian Reserve Function', 'Survivorship', 'Disease-free Survival', 'Overall Survival']}, 'descriptionModule': {'briefSummary': 'This is prospective cohort study. All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. Before and after the major therapy (including at least radical hysterectomy and/or radiotherapy), the patients accept (1) the questionnaires survey about quality of life; (2) urodynamic testing; (3) rectum dynamics testing and (4) ovarian reserve function. The survival outcomes (disease-free survival and overall survival) will be supplemented as secondary objectives.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. They should be 18 years or older, accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study cente and achieving response after the major therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary uterine cervical carcinomas\n* Aged 18 or older\n* Accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study center\n* Informed consents delivered\n\nExclusion Criteria:\n\n* Not meeting any of the inclusion criteria\n* Not accepting any of the four kinds of evaluations for quality of life\n* Recurrent patients\n* Not achieving response after above major therapy'}, 'identificationModule': {'nctId': 'NCT03967457', 'briefTitle': 'Comprehensive Study on the Quality of Life in Cervical Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'CCQOL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaires survey', 'type': 'DIAGNOSTIC_TEST', 'description': 'Including four kinds of questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3); EORTC QLQ-CX24; Eligibility Criteria (FSFI); and Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFIQ-7)'}, {'name': 'Urodynamic testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urodynamic testing consists of important urodynamic parameters including:\n\nBladder capacity at the first void sense Bladder capacity at normal desire to void Bladder capacity at strong desire to void Qmax Qave Pves at Qmax Pdet at Qmax Cves at SDV Cdet at SDV Residual urine volume'}, {'name': 'Rectum dynamics testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Rectum dynamics testing consists of important parameters of rectum activities'}, {'name': 'ovarian reserve function', 'type': 'DIAGNOSTIC_TEST', 'description': 'Testing for ovarian reserve function consists of:\n\nFollicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '008613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '+8613911988831'}], 'overallOfficials': [{'name': 'Lei Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}