- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00315653
Survivin Urine mRNA Assay Risk of Bladder Cancer Study
Evaluation of the Survivin Urine mRNA Assay to Estimate Risk of Bladder Cancer Found on Cystoscopy
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Bladder cancer is the fourth most common cancer in men and ninth most common cancer in women, accounting for more than 60,000 new cases and ~12,000 deaths in North America in 2004. Cystoscopy and urinary cytology is the standard of care for detection of bladder cancer, but cystoscopy is expensive and invasive, while cytology has low sensitivity. New, noninvasive, diagnostic tools for bladder cancer detection have been developed, but their application in clinical practice has been limited due to low sensitivity and specificity of the assays. Survivin, an anti-apoptotic protein, is capable of regulating both cell proliferation and apoptotic cell death, and is over-expressed in most human cancers but not in normal adult tissues. The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with no prior history of bladder cancer presenting with microscopic or macroscopic hematuria.
This study is designed to be a prospective, multicenter, double blind, clinical study in subjects >50 years old with no prior history of bladder cancer and confirmed hematuria (microscopic and/or macroscopic) presenting to a urologist.
The primary objective of the study is to estimate the risk of bladder cancer at the time of cystoscopy in subjects >50 years old with no prior history of bladder cancer and confirmed hematuria using urinary Survivin mRNA levels.
The secondary objective of the study is for comparison of a multivariate predictive algorithm using urinary Survivin mRNA levels and subject risk factors, such as age, sex, race, and smoking history, for estimation of the risk of bladder cancer at the time of cystoscopy in subjects >50 years old with no prior history of bladder cancer and confirmed hematuria to the use of urinary Survivin mRNA levels alone.
Type d'étude
Inscription
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Malvern, Pennsylvania, États-Unis, 19355
- Fujirebio Diagnostics, Inc
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Population étudiée
La description
Inclusion Criteria:
- Able to understand and sign Informed Consent;
- Age >50 years old;
- Males or females;
- Subjects must have confirmed micro-hematuria, defined as any positive urine reagent strip test for blood (i.e. finding of "Trace" or higher amounts of blood) and/or >3 RBC per high power field on microscopic examination, or macro-hematuria, defined as visible blood in the urine sample;
- All subjects must be scheduled to undergo a cystoscopy evaluation;
- All subjects must have upper tract imaging performed within +/- 4 weeks of the cystoscopic evaluation.
Exclusion Criteria:
- Previous history of bladder cancer;
- Previous history of other cancers except for non-melanoma skin cancer;
- Prior pelvic radiation;
- Active urinary or vaginal infection;
- Any evidence of vaginal or rectal bleeding;
- Currently receiving chemotherapies such as cyclophosphamide or methotrexate;
- Unable to provide informed consent or a high risk that the subject may not comply with the protocol requirements.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: William J Allard, PhD, Fujirebio Diagnostics, Inc.
- Chercheur principal: Jose G Moreno, MD, Tri County Urologic Associates, PC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
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
- FDI-01 Sure Study
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