Stage III Bladder Cancer Clinical Trial
Official title:
MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma
Verified date | August 2022 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This pilot research trial studies how well myeloid derived suppressor cells (MDSC) clinical assay works in finding and monitoring cancer cells in blood and urine samples from patients with or without localized or metastatic bladder cancer. Studying samples of blood and urine from patients with or without bladder cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and may help doctors improve ways to diagnose and treat patients.
Status | Terminated |
Enrollment | 10 |
Est. completion date | April 13, 2022 |
Est. primary completion date | April 13, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Subjects must meet the criteria for one of the three following groups: - Normal patients- aged 40 years and older with no evidence of hematuria or cancer - Patients with localized bladder cancer diagnosed by cystoscopy and pathology: T2N0M0 or T3N0M0 who have not received neoadjuvant chemotherapy - Patients with metastatic bladder cancer: newly diagnosed with no previous treatment for metastatic disease - Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: - For normal subject arm: evidence of cancer or hematuria - For localized bladder cancer: evidence of metastatic disease, second cancer, prior chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - For metastatic bladder cancer: prior therapy for metastatic disease - Uncontrolled intercurrent illness including, but not limited to previous or current history of second malignancy unrelated to bladder cancer; autoimmune disease or immune deficiency, chronic treatment with immunomodulatory therapies (e.g. glucocorticoids); significant trauma, surgery, or infection in the past two weeks or psychiatric illness/social situations that would limit compliance with study requirements |
Country | Name | City | State |
---|---|---|---|
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment | Baseline to up to 4 months | ||
Primary | Change in MDSC level in patients with known metastatic bladder cancer who undergo systemic treatment | The direction and magnitude of the changes in Group 3 will be compared to the changes in tumor burden assessed radiographically - to explore the associations. | Baseline to up to 6 months | |
Primary | Change in MDSC level in patients with no history of cancer | Baseline to 4 months | ||
Primary | Change in tumor burden evaluated by radiographic imaging | Baseline to up to 1 year | ||
Secondary | Change in urine cytology analysis | The MDSC levels at baseline will be compared (plots and correlations) to the urine cytology levels (Groups 2 and 3) to describe any associations; for Group 3, the changes (baseline to post treatment) in the MDSC levels will be compared to the changes in urine cytology. | Baseline to up to 4 months |
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