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Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer

9. januar 2014 opdateret af: University of Birmingham

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.

Studieoversigt

Status

Ukendt

Betingelser

Blærekræft

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding

1600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Det Forenede Kongerige
- England
  - Edgbaston, England, Det Forenede Kongerige, B15 2TT
    - Rekruttering
    - University of Birmingham
    - Kontakt:
      
      Maurice Zeegers
      
      Telefonnummer: 44-121-414-6721

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Recurrence at 5 years
Progression at 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Birmingham

Efterforskere

Studiestol: Maurice Zeegers, University of Birmingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2005

Datoer for studieregistrering

Først indsendt

2. november 2007

Først indsendt, der opfyldte QC-kriterier