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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription
Contacts et emplacements
Lieux d'étude
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England
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Edgbaston, England, Royaume-Uni, B15 2TT
- Recrutement
- University of Birmingham
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Contact:
- Maurice Zeegers
- Numéro de téléphone: 44-121-414-6721
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Recurrence at 5 years
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Progression at 5 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Maurice Zeegers, University of Birmingham
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000574078
- ISRCTN13889738
- EU-20768
- CRUK-BCPP-2005-01-COHORT
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