Track topics on Twitter Track topics that are important to you
The purpose of the study is to establish the clinical performance and utility of the miR Sentinel™ BCa Test, a urine exosome-based diagnostic test, as an aid in diagnosing bladder cancer. Male and female participants presenting with micro- or macro-hematuria who are undergoing cystoscopy for diagnosis of bladder cancer will be eligible for the study. Urine samples will be collected at the time of the first presentation, and the miR Sentinel™ BCa Score determined and compared to the results of cystoscopy. Participants with no evidence of cancer following cystoscopy will be designated cancer-free, while those participants with a positive cystoscopy and histopathological evidence of cancer will be designated as having bladder cancer. Participants with a positive cystoscopy who subsequently undergo TURBT will be eligible to continue in the study. Urine samples will be collected at each follow up visit for up to three years, and the miR Sentinal™ BCR Score will be determined and compared to the results of surveillance cystoscopy.
Establish the performance characteristics of the miR Sentinel™ BCa Test as an aid in diagnosing bladder cancer in men and women presenting with hematuria.
Secondary Objective(s) Establish the performance characteristics of the miR Sentinel™ BCR Test in identifying bladder cancer patients with recurrent disease.
Participants who present with evidence of hematuria (micro- or macro-hematuria) and are scheduled to have cystoscopy will be enrolled. All participants will provide a urine sample for the miR Sentinel™ BCa Test prior to cystoscopy for bladder cancer. The presence or absence of cancer will be determined by cystoscopy. Diagnosis of bladder cancer will be confirmed by histopathology. The performance of the miR Sentinel™ BCa Test for classifying future patients as either bladder cancer or no bladder cancer will be established. The sensitivity, specificity, positive and negative predictive value determined for the miR Sentinel™ BCa Test and will be compared to cystoscopy.
Definitions. The general notation P(A | B) means the probability (prevalence) of the event A among the subgroup of patients in a population all of whom have the event B.
1. Sensitivity = P(screening test + | disease).
2. Specificity = P(screening test - | no disease).
3. PPV = P(disease | screening test + ).
4. NPV = P(no disease | screening test -).
Estimate of Sample Size. This study is targeted to enroll 3000 participants, 1500 males and 1500 females, who present with hematuria. Approximately 15% of participants with hematuria have bladder cancer; men have a higher incidence of bladder cancer than women. Therefore, the investigators anticipate that 225 males (15% of all males enrolled) and 175 females (approximately 12% of all women enrolled) will have bladder cancer confirmed by histopathology.
Overview. As outlined below, this clinical study will enroll male and female participants that have been identified as having (micro- or macro-) hematuria and are therefore at risk for bladder cancer and meet clear eligibility criteria. The study will evaluate the miR Sentinel™ BCa Test for classification of participants as cancer or no cancer, to be used as an aid in diagnosing bladder cancer. For participants diagnosed with bladder cancer who undergo TURBT will be eligible to continue in the study of miR Sentinel™ BCR Test to monitor for recurrent disease in conjunction with the cystoscopy associated with the standard of care recommended by the AUA.
The miR Sentinel™ BCa Test functions by controlling sensitivity at or above a pre-specified level, denoted 1-α; where α is the false-negative rate of the test (a patient who truly has bladder cancer has a negative test result), For example, the value that has been assumed in this design is α≤0.05 so that sensitivity is at least 95%. To describe how the cutoff for the miR Sentinel™ BCa Test is calculated to control sensitivity, for each participant determined to have bladder cancer by histopathology, the miR Sentinel™ BCa Score will be calculated using an approach that blinds each participant's true cancer status, mimicking the setting for classification of a future patient. The cutoff value for the Sentinel™ Score is then chosen so that the empirical sensitivity, calculated over all patients in the training dataset, yields a 95% upper confidence interval with lower limit 1-α.
To provide some detail on the calculation of the error rates of the test, the method to be used for estimation is cross-validation. Cross-validation produces unbiased estimators of error rates for classification of a future patient, with unknown true disease status, as the number of patients in the training dataset grows large. If there are 3000 participants with hematuria divided equally from male and female population in the study and 225 males and 175 females with bladder cancer, then, for males, the upper 95% confidence interval based on an observed empirical sensitivity of 97% (218/225) will have a lower bound of 0.95, and for females, the upper 95% confidence interval based on an observed empirical sensitivity of 98% (171/175) will have a lower bound of 0.95.
Validation of the miR Sentinel™ BCR for identifying patients with recurrent disease uses essentially the same statistical methodology. However, the classification is based on the comparison of the miR Sentinel™ BCR signature for patients with stable (non-recurrent disease) and patients with evidence of progressive (recurrent) disease. The longitudinal monitoring of participants diagnosed with bladder cancer by cystoscopy may provide additional information related to anticipatory changes in the Sentinel™ signature indicative of recurrence.
Integrated Medical Professionals
Not yet recruiting
miR Scientific LLC
Published on BioPortfolio: 2019-11-12T18:25:31-0500
The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent ...
The purpose of this study is to learn about the quality of life of people living with bladder cancer. We are interested in learning about how the treatments for bladder cancer affect peopl...
A multidisciplinary approach has led to the development of bladder-preservation therapy using maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing ch...
The purpose of this study is to examine the effect of androgen deprivation therapy through administration of enzalutamide on preventing bladder cancer recurrences in patients with non-musc...
The primary objective of this prospective, single-centre study is to establish the clinical performance characteristics of Xpert Bladder Cancer Monitor on the GeneXpert Instrument Systems ...
Although long noncoding RNA TUC338 has been characterized as an oncogene, its role in bladder cancer is unknown. The purpose of the present study is to investigate the function of TUC338 in bladder ca...
Bladder cancer care is costly, including cost to Medicare, but the medical cost associated with bladder cancer patients relative to identical persons without bladder cancer is unknown.
Bladder cancer (BC) is a common urothelial malignancy, characterized by a high recurrence rate. The biology of bladder cancer is complex and needs to be deciphered. The latest evidence reveals the cr...
Bladder cancer is the ninth most common cancer, expected to lead to an estimated 17,670 deaths in the United States in 2019. Clinical management and prognosis of bladder cancer mainly depend on the ex...
Studies have shown a high risk of tumor development within a bladder diverticulum (BD). We were interested in the relationship between BD and the development of bladder cancer. Herein, we attempted to...
Tumors or cancer of the URINARY BLADDER.
A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.
Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.
An abnormal passage in the URINARY BLADDER or between the bladder and any surrounding organ.
Blocked urine flow through the bladder neck, the narrow internal urethral opening at the base of the URINARY BLADDER. Narrowing or strictures of the URETHRA can be congenital or acquired. It is often observed in males with enlarged PROSTATE glands.
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...
Non-invasive bladder cancer is a cancer that is only in the inner lining of the bladder. Invasive bladder cancer is cancer that has spread into the deeper walls of the bladder. When the cancer has spread outside the bladder to other parts of the body, th...
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...