Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-04 @ 4:19 PM
Study NCT ID:
NCT00553566
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2007-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'count': 1600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2007-11-02', 'studyFirstSubmitQcDate': '2007-11-02', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence at 5 years'}, {'measure': 'Progression at 5 years'}]}, 'conditionsModule': {'keywords': ['stage 0 bladder cancer', 'stage I bladder cancer', 'transitional cell carcinoma of the bladder'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental factors on the risk of cancer progression and recurrence may help the study of bladder cancer in the future.\n\nPURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.', 'detailedDescription': "OBJECTIVES:\n\n* To examine if common and potentially modifiable dietary, lifestyle, and environmental exposures affect the risk of recurrence and progression in bladder cancer.\n\nOUTLINE: This is a multicenter study.\n\nDetailed information will be collected about the patients' lifestyle and their exposure to risk factors associated with bladder cancer using semi-structured questionnaires. A baseline questionnaire will be administered at the time of diagnosis and will collect information about socio-demographics, environmental exposures, medical history, diet, health-related quality of life, and social support.\n\nFurther questionnaires will be administered at regular follow-up visits to capture information relating to changes in exposure. A postal questionnaire will be used to collect historical information that may require the patient to check records or consult family or friends. Patients will also be asked to keep a 1-week food, fluid, and micturition diary.\n\nPatients continue to complete questionnaires at 3 months and then annually for up to 5 years.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\nInclusion criteria:\n\n* Enrolled on parent protocol CRUK-BCPP-2005-01\n* Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma\n* Histologically proven urothelial cancer meeting one of the following criteria:\n\n * Stage Ta (WHO grade 2/3, or grade 1 tumors that are either multifocal or \\> 3 cm in size)\n * Stage T1 (any grade)\n * Stage Tis\n\nExclusion criteria:\n\n* Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis\n\nPATIENT CHARACTERISTICS:\n\nInclusion criteria:\n\n* Fit for cystoscopy and surgical biopsy/resection\n\nExclusion criteria:\n\n* HIV infection\n* Any condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00553566', 'briefTitle': 'Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]', 'orgStudyIdInfo': {'id': 'CDR0000574078'}, 'secondaryIdInfos': [{'id': 'CRUK-BCPP-2005-01-COHORT'}, {'id': 'ISRCTN13889738'}, {'id': 'EU-20768'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'medical chart review', 'type': 'PROCEDURE'}, {'name': 'questionnaire administration', 'type': 'PROCEDURE'}, {'name': 'study of socioeconomic and demographic variables', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Edgbaston', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Maurice Zeegers', 'role': 'CONTACT', 'phone': '44-121-414-6721'}], 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.4623, 'lon': -1.92115}}], 'overallOfficials': [{'name': 'Maurice Zeegers', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}}}}