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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学
連絡先と場所
研究場所
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England
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Edgbaston、England、イギリス、B15 2TT
- 募集
- University of Birmingham
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コンタクト：
- Maurice Zeegers
- 電話番号：44-121-414-6721
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
|---|
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Recurrence at 5 years
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Progression at 5 years
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Maurice Zeegers、University of Birmingham
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。