No Evidence of DiseaseNCT02735512
MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer
An observational study of No Evidence of Disease and Stage II Bladder Cancer, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- No Evidence of Disease, Stage II Bladder Cancer, Stage III Bladder Cancer
- What is being tested?
- Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 13 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate a novel clinical assay (MDSC clinical assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant bladder cancer in patients.
II. Estimate mean MDSC level, intra-patient variability, and inter-patient variability, for 3 groups of subjects with variable bladder cancer disease status at baseline.
III. In patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment: to determine the change in MDSC level from baseline to after treatment including surgery.
IV. In patients with known metastatic bladder cancer who undergo systemic treatment: to determine the change in MDSC level from baseline to after 4 cycles of treatment compared to the change in tumor burden as evaluated by radiographic imaging.
- In patients with no history of cancer: to determine the changes in MDSC levels from baseline to after 4 months.
SECONDARY OBJECTIVES:
- Compare MDSC level measurements to urine cytology analysis at baseline and after treatment to determine whether the two tests correlate in any of the 3 groups of patients defined in this study.
OUTLINE:
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.
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.
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.
- Conditions
- No Evidence of Disease, Stage II Bladder Cancer, Stage III Bladder Cancer, Stage IVA Bladder Cancer, Stage IVB Bladder Cancer
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo collection of blood and urine samples
Laboratory Biomarker AnalysisOther
Samples undergo MDSC clinical assay
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment
Measured: 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.
Measured: Baseline to up to 6 months
Change in MDSC level in patients with no history of cancer
Measured: Baseline to 4 months
Change in tumor burden evaluated by radiographic imaging
Measured: Baseline to up to 1 year
Secondary outcomes (1)
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.
Measured: Baseline to up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start1 Mar 2016
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jacek Pinski, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735512
- Sponsor's protocol ID
- 4B-15-2
- Other IDs
- NCI-2016-00265, 4B-15-2, P30CA014089
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2016
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDSC Clinical Assay for Cancer Detection and Monitoring in Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT02735512
- Acronym / sponsor ID
- 4B-15-2
- Conditions
- No Evidence of Disease, Stage II Bladder Cancer, Stage III Bladder Cancer, Stage IVA Bladder Cancer, Stage IVB Bladder Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate a novel clinical assay (MDSC clinical assay) to detect cancer associated immune cells in the peripheral blood of patients as a means to better detect and monitor malignant bladder cancer in patients.
II. Estimate mean MDSC level, intra-patient variability, and inter-patient variability, for 3 groups of subjects with variable bladder cancer disease status at baseline.
III. In patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment: to determine the change in MDSC level from baseline to after treatment including surgery.
IV. In patients with known metastatic bladder cancer who undergo systemic treatment: to determine the change in MDSC level from baseline to after 4 cycles of treatment compared to the change in tumor burden as evaluated by radiographic imaging.
- In patients with no history of cancer: to determine the changes in MDSC levels from baseline to after 4 months.
SECONDARY OBJECTIVES:
- Compare MDSC level measurements to urine cytology analysis at baseline and after treatment to determine whether the two tests correlate in any of the 3 groups of patients defined in this study.
OUTLINE:
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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients without cancer undergo collection of blood and urine samples for analysis via MDSC clinical assay at baseline, 1 week, and 4 months. |
| Group II | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients 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. |
| Group III | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Subjects must meet the criteria for one of the three following groups:
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo collection of blood and urine samples | Other | Group I, Group II, Group III |
| Laboratory Biomarker AnalysisSamples undergo MDSC clinical assay | Other | Group I, Group II, Group III |
Primary outcome
Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment
Time frame: Baseline to up to 4 months
Change in MDSC level in patients with known metastatic bladder cancer who undergo systemic treatment
Time frame: Baseline to up to 6 months
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.
Change in MDSC level in patients with no history of cancer
Time frame: Baseline to 4 months
Change in tumor burden evaluated by radiographic imaging
Time frame: Baseline to up to 1 year
1 secondary outcome
Change in urine cytology analysis
Time frame: Baseline to up to 4 months
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Pinski principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of No Evidence of Disease and Stage II Bladder Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDSC level in patients with known localized, muscle-invasive bladder cancer who undergo surgical treatment (time frame: Baseline to up to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.