- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00553566
Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [COHORT]
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.
PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- To examine if common and potentially modifiable dietary, lifestyle, and environmental exposures affect the risk of recurrence and progression in bladder cancer.
OUTLINE: This is a multicenter study.
Detailed 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.
Further 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.
Patients continue to complete questionnaires at 3 months and then annually for up to 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
연구 유형
등록
연락처 및 위치
연구 장소
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England
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Edgbaston, England, 영국, B15 2TT
- 모병
- University of Birmingham
-
연락하다:
- Maurice Zeegers
- 전화번호: 44-121-414-6721
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Inclusion criteria:
- Enrolled on parent protocol CRUK-BCPP-2005-01
- Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma
Histologically proven urothelial cancer meeting one of the following criteria:
- Stage Ta (WHO grade 2/3, or grade 1 tumors that are either multifocal or > 3 cm in size)
- Stage T1 (any grade)
- Stage Tis
Exclusion criteria:
- Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Fit for cystoscopy and surgical biopsy/resection
Exclusion criteria:
- HIV infection
- Any condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives
PRIOR CONCURRENT THERAPY:
- Not specified
공부 계획
연구는 어떻게 설계됩니까?
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Recurrence at 5 years
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Progression at 5 years
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공동 작업자 및 조사자
수사관
- 연구 의자: Maurice Zeegers, University of Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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