Bladder cancer is a common malignancy; it is the 4th most common cancer in males and the 9th in females. The presenting symptom is usually blood in the urine, and diagnosis is currently based on cystoscopy, which is invasive, costly, painful and time consuming. To date, no biomarker has been identified in the urine that might be used for screening, staging, prognosis and monitoring treatment. We now report that the amount of the 60 kDa heat shock protein (HSP60) in a subject’s urine is a biomarker for muscle invasion in patients with bladder cancer – stage T2 and higher. Moreover, subjects with stage T1 disease can be stratified by their urine levels of HSP60 into a sub-group likely to progress into stage T2 or into a sub-group more likely to respond to conservative treatment with BCG, which does not require removal of the bladder. The distinction between these two sub-groups of T1 bladder cancer can identify earlier subjects in need of cystectomy, while sparing others unnecessary major surgery.
1. Screening subjects with overt hematuria, or at risk of developing bladder cancer (such as heavy smokers);
2. Stratifying bladder cancer subjects;
4. Determining treatment program;
5. Monitoring response to therapy.
2. Easy to apply;
3. Relatively inexpensive;
Quantitative measurement of HSP60 levels in a subject’s urine by ELISA, radio-immunoassay or other simple assays.