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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学
連絡先と場所
研究場所
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Pennsylvania
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Malvern、Pennsylvania、アメリカ、19355
- Fujirebio Diagnostics, Inc
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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
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
協力者と研究者
捜査官
- スタディディレクター:William J Allard, PhD、Fujirebio Diagnostics, Inc.
- 主任研究者:Jose G Moreno, MD、Tri County Urologic Associates, PC
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
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。
膀胱がんの臨床試験
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