MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer

NCT02735512 | Terminated DMC

• 3 other identifiers: 4B-15-2NCI-2016-00265P30CA014089
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

No Evidence of Disease; Stage II Bladder Cancer; Stage III Bladder Cancer; Stage IVA Bladder Cancer; Stage IVB Bladder Cancer

Outcome Measures

Primary Outcomes (4)

• Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment

  Baseline to up to 4 months

• 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

• Change in MDSC level in patients with no history of cancer

  Baseline to 4 months

• Change in tumor burden evaluated by radiographic imaging

  Baseline to up to 1 year

Secondary Outcomes (1)

• Change in urine cytology analysis

  Baseline to up to 4 months

Study Arms (3)

Group I

Patients without cancer undergo collection of blood and urine samples for analysis via MDSC clinical assay at baseline, 1 week, and 4 months.

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Group II

Patients with localized bladder cancer undergo collection of blood and urine samples for analysis via MDSC clinical assay at baseline, 1 week, and within 4 weeks after cystectomy.

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Group III

Patients with metastatic cancer undergo collection of blood and urine samples for analysis via MDSC clinical assay at baseline, 1 week, and within 4 weeks after completion of 4 courses of systemic chemotherapy.

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Interventions

Cytology Specimen Collection Procedure OTHER

Undergo collection of blood and urine samples

Also known as: Cytologic Sampling

Group I; Group II; Group III

Laboratory Biomarker Analysis OTHER

Samples undergo MDSC clinical assay

Group I; Group II; Group III

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jacek Pinski

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

US (1)