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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05982561 |
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Recruitment Status : **RECRUITING NOW**
First Posted : August 8, 2023 Last Update Posted : August 8, 2023 |
Sponsor:
Information provided by (Responsible Party):
Early is Good Inc.
Brief Summary:
BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.
| Bladder Cancer |
Detailed Description:
BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent NMIBC in patients with a history of bladder cancer undergoing surveillance.
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer |
| Actual Study Start Date : | July 26, 2023 |
| Estimated Primary Completion Date : | July 31, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
- Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard) [ Time Frame: Participants’ urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics. ]
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| Ages Eligible for Study:  | 22 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Non-Probability Sample |
Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC) follow-up.
Inclusion Criteria:
- Patients 22 Years and older
- Patients who have been diagnosed with incident or recurrent NMIBC within the past 2 years and undergoing standard of care/routine monitoring cystoscopy.
- Patients who are able to provide legally effective informed consent.
- Patients who are able to provide minimum 40mL of voided urine.
Exclusion Criteria:
- Patients planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05982561
| Arkansas Urology Research Center | |
| Little Rock, Arkansas, United States, 72211 | |
| Contact: Marotte, Â Â Â Â Â Â | |
| Principal Investigator: Jeff Marotte, MD Â Â Â Â Â Â | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: Hristos Kaimakliotis, MD Â Â Â Â Â Â | |
| Washington University | |
| Saint Louis, Missouri, United States, 63130 | |
| Principal Investigator: Eric Kim, MD Â Â Â Â Â Â | |
Early is Good Inc.
| Responsible Party: | Early is Good Inc. |
| ClinicalTrials.gov Identifier: | NCT05982561 Â Â |
| Other Study ID Numbers: | EIG 2023-02 |
| First Posted: | August 8, 2023 Â Â Key Record Dates |
| Last Update Posted: | August 8, 2023 |
| Last Verified: | August 2023 |
Additional relevant MeSH terms:
| Urinary Bladder Neoplasms Non-Muscle Invasive Bladder Neoplasms Recurrence Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Disease Attributes Pathologic Processes Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
