Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNatera, Inc.
About this trial
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC). Study participants will undergo research blood and urine collections, as well as tumor tissue collected as part of a standard-of-care procedure(s), for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays ("Natera cancer monitoring and detection test(s)").
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is at least 18 years of age or older.
Eastern Cooperative Oncology Group performance status ≤ 2.
Patient has a suspected high risk non-muscle invasive bladder cancer.
High grade T1.
Disqualifiers
Pregnant or breastfeeding.
Prior history and treatment for any cancer (including muscle invasive bladder cancer) within the past year, or if they have any other active cancer, with the exception of participants who have undergone surgical removal of basal or squamous skin cancers, as well as those who have received NMIBC-directed therapy, including those undergoing cystectomy for primary NMIBC or after recurrence/progression of NMIBC.
Diagnosis of >T1 bladder cancer at time of enrollment.
Tumor tissue unavailable and/or consists only of carcinoma in situ (CIS) disease.
Trial population
Participants 18 years of age or older diagnosed with Non-muscle Invasive Bladder Cancer (NMIBC) prior to receiving treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 3 trial groupsGroup A: Cohort A - Intravesical Therapy
Group B: Cohort A - Systemic Therapy
Group C: Cohort B - Cystectomy
Trial outcomes
Primary outcomes
1
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Collected
The primary outcome will be measured as the number of participants who complete collection of clinically characterized, de-identified whole blood, urine and residual tissue specimens. The planned number of completed participants is 225. The specimens and data will be used in development and validation of cancer monitoring and detection assays.
Time frame
3 YearsSecondary outcomes
1
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Evaluated for Biomarkers
The secondary outcome will be measured as the number of completed participants whose clinically characterized, de-identified whole blood, urine and residual tissue specimens are evaluated for biomarkers associated with the development and validation of disease assays. The planned number of completed participants is 225.
Time frame
3 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov