Stage II Bladder Urothelial CarcinomaNCT02514408
Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer
An observational study of Stage II Bladder Urothelial Carcinoma, run by University of Southern California.
Trial summary
This pilot clinical trial studies the impact of radical cystectomy (surgery) on the expulsion (release) of circulating tumor cells into the blood stream in patients with bladder cancer. Significant surgery such as radical cystectomy may cause the expulsion of tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Bladder Urothelial Carcinoma
- What is being tested?
- Catheter Management, Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2018to 5 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with transitional cell bladder cancer scheduled to undergo open radical cystectomy.
Who may be able to join
- Must meet all inclusion and exclusion criteria
- Presence of a muscle invasive bladder tumor(s) (T2), specific for transitional cell carcinoma on pre-operative histology (i.e. biopsy or trans-urethral resection of bladder tumor [TURBT])
- Presence of a single bladder tumor lesion
- Patients are scheduled to undergo ORC at our institution
- Subjects must have given written informed consent to agree to participate
- Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery
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- Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
- Absolute neutrophil count (ANC) >= 1500 mm^-3
- Platelet count >= 100,000 mm^-3
- Hemoglobin >= 10 g/dl
- Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)
- Activated partial thromboplastin time =< 1.5 times ULN
- Total bilirubin < 1.5 times ULN
- Aspartate aminotransferase (AST) =< 3 times ULN
- Alkaline phosphatase < 2 times ULN, unless arising from bone
Who cannot join
- Subjects deemed unsuitable candidates and not medically optimized for ORC
- Subjects with tumors lying < 1 cm from sensitive structures such as the ureter, prostate or adjacent bowel
- Patients with presence of multiple bladder lesions
- Patients with pre-operative histologic confirmation of a bladder lesion other than transitional cell carcinoma
- Subjects on concurrent anticoagulant, or immunosuppressive medication
- Subjects on anti-cancer medication whether biologic or pharmaceutical
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- Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to high intensity frequency ultrasound [HIFU] treatment)
- Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
- Absolute Contraindications: venous injury at the level of the femoral veins or proximally; known or suspected thrombosis of the femoral or iliac veins on the proposed side of venous annulation, ambulatory patient
- Relative Contraindications: presence of bleeding disorders; distortion of anatomy due to local injury or deformity; previous long-term venous catheterization; history of vasculitis; previous injection of sclerosis agents; previous radiation therapy
About this study
Official title: The Impact Radical Cystectomy Has on the Expulsion of Circulating Tumor Cells
This pilot clinical trial studies the impact of radical cystectomy (surgery) on the expulsion (release) of circulating tumor cells into the blood stream in patients with bladder cancer. Significant surgery such as radical cystectomy may cause the expulsion of tumor cells. Studying the release of tumor cells into the circulation may help doctors understand the impact that radical cystectomy has on tumor metastasis and/or tumor recurrence.
Read the detailed description
PRIMARY OBJECTIVES:
- To detect the numbers of circulating tumor cells (CTCs) during and following radical cystectomy in both the peripheral and central line.
SECONDARY OBJECTIVES:
- To ensure the safety and of using the femoral vein to access the central venous blood supply for patients with primary bladder cancer and the withdrawal of blood from both a peripheral and central line.
OUTLINE:
Patients undergo placement of a central line via the right femoral vein and undergo open radical cystectomy (ORC). Blood samples are collected and analyzed for CTCs pre-surgery, at 30 minutes and 1 hour once ORC begins, post-surgery, and 7 days after surgery.
After completion of study, patients are followed up at 2 weeks and at 1 month.
- Conditions
- Stage II Bladder Urothelial Carcinoma
- Being tested
- Catheter Management, Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ManagementProcedure or surgery
Also called management of catheter
Insertion of venous catheter under ultrasound guidance
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Collection of blood samples
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (collection of blood samples) | Patients undergo placement of a central line via the right femoral vein and undergo ORC. Blood samples are collected and analyzed for CTCs pre-surgery, at 30 minutes and 1 hour once ORC begins, post-surgery, and 7 days after surgery. Receives: Procedure: Catheter Management; 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.
Number of CTCs in the blood drawn from central line
Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.
Measured: Up to post-operative day 7
Number of CTCs in the blood drawn from peripheral line
Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.
Measured: Up to post-operative day 7
Secondary outcomes (1)
Incidence of complications during the cannulation of the femoral vein
All complications will be recorded that occur during the insertion of femoral line, at any time during the surgical procedure or within 30 days of discharge from the hospital
Measured: Up to 1 month from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start5 Feb 2018 (estimated)
- Primary completion5 Feb 2019 (estimated)
- Study completion5 Mar 2019 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Bladder Urothelial CarcinomaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 0 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
- Inderbir Gill, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514408
- Sponsor's protocol ID
- 4B-15-7
- Other IDs
- NCI-2015-01063, 4B-15-7, P30CA014089
- Status last verified
- Dec 2017
- First submitted
- 30 Jul 2015
- Last updated
- 2 Jan 2018
- 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 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Radical Cystectomy Has on the Expulsion of Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT02514408
- Acronym / sponsor ID
- 4B-15-7
- Conditions
- Stage II Bladder Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Feb 2018 (estimated)
- Primary completion
- 5 Feb 2019 (estimated)
- Study completion
- 5 Mar 2019 (estimated)
- First posted
- 3 Aug 2015 (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 clinical trial studies the impact of radical cystectomy (surgery) on the expulsion (release) of circulating tumor cells into the blood stream in patients with bladder cancer. Significant surgery such as radical cystectomy may cause the expulsion of tumor cells. Studying the release of tumor cells into the circulation may help doctors understand the impact that radical cystectomy has on tumor metastasis and/or tumor recurrence.
Detailed description
PRIMARY OBJECTIVES:
- To detect the numbers of circulating tumor cells (CTCs) during and following radical cystectomy in both the peripheral and central line.
SECONDARY OBJECTIVES:
- To ensure the safety and of using the femoral vein to access the central venous blood supply for patients with primary bladder cancer and the withdrawal of blood from both a peripheral and central line.
OUTLINE:
Patients undergo placement of a central line via the right femoral vein and undergo open radical cystectomy (ORC). Blood samples are collected and analyzed for CTCs pre-surgery, at 30 minutes and 1 hour once ORC begins, post-surgery, and 7 days after surgery.
After completion of study, patients are followed up at 2 weeks and at 1 month.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (collection of blood samples) | – | Procedure: Catheter Management, Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients undergo placement of a central line via the right femoral vein and undergo ORC. Blood samples are collected and analyzed for CTCs pre-surgery, at 30 minutes and 1 hour once ORC begins, post-surgery, and 7 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with transitional cell bladder cancer scheduled to undergo open radical cystectomy.
Key inclusion criteria (15 listed)
- Must meet all inclusion and exclusion criteria
- Presence of a muscle invasive bladder tumor(s) (T2), specific for transitional cell carcinoma on pre-operative histology (i.e. biopsy or trans-urethral resection of bladder tumor [TURBT])
- Presence of a single bladder tumor lesion
- Patients are scheduled to undergo ORC at our institution
- Subjects must have given written informed consent to agree to participate
Key exclusion criteria (10 listed)
- Subjects deemed unsuitable candidates and not medically optimized for ORC
- Subjects with tumors lying < 1 cm from sensitive structures such as the ureter, prostate or adjacent bowel
- Patients with presence of multiple bladder lesions
- Patients with pre-operative histologic confirmation of a bladder lesion other than transitional cell carcinoma
- Subjects on concurrent anticoagulant, or immunosuppressive medication
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 |
|---|---|---|
| Catheter ManagementAlso: management of catheterInsertion of venous catheter under ultrasound guidance | Procedure or surgery | Ancillary-Correlative (collection of blood samples) |
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingCollection of blood samples | Other | Ancillary-Correlative (collection of blood samples) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (collection of blood samples) |
Primary outcome
Number of CTCs in the blood drawn from central line
Time frame: Up to post-operative day 7
Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.
Number of CTCs in the blood drawn from peripheral line
Time frame: Up to post-operative day 7
Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.
1 secondary outcome
Incidence of complications during the cannulation of the femoral vein
Time frame: Up to 1 month from discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
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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.
Inderbir Gill, MD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
An observational study of Stage II Bladder Urothelial Carcinoma, run by University of Southern California.
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 15 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Number of CTCs in the blood drawn from central line (time frame: Up to post-operative day 7). The study lists 2 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 2 Jan 2018.