Bladder CancerCirCanCellNCT02345473
Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy
An observational study of Bladder Cancer and Circulating Tumor Cells, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
Very few factors may be identified as prognostic for patients with bladder cancer undergoing radical cystectomy. Recently, detection of circulating tumor cells has shown to be very promising in anticipating both the likelyhood of distant metastases and survival in patients with breast cancer, melanoma, prostate cancer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Circulating Tumor Cells
- What is being tested?
- Detection of circulating tumor cells in blood samples
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2005to Oct 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing radical cystectomy for bladder cancer and healthy volunteers
Who may be able to join
- Prior trans urethral resection of the bladder (TUR)
- Histological confirmation of a transitional cell carcinoma (TCC) of the bladder
- ECOG Performance Status ≤ 2
- WBC count ≥4,000/μL; platelet count ≥150,000/μL; creatinine ≤1.8 mg/dL; AST, ALT, and alkaline phosphatase ≤2X the upper limit of normal, normal total bilirubin
- recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Who cannot join
- Neo-adjuvant chemotherapy (either planned or already performed)
- Patients receiving investigational medications
- Subjects not suitable for a radical cystectomy
- Patients not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Very few factors may be identified as prognostic for patients with bladder cancer undergoing radical cystectomy. Recently, detection of circulating tumor cells has shown to be very promising in anticipating both the likelyhood of distant metastases and survival in patients with breast cancer, melanoma, prostate cancer and other malignancies. In the present study we both tested the detection rate of circulating tumor cells using a PCR based methodology in the peripheral blood of patients undergoing radical cystectomy, and we further correlated our results with their clinical outcome.
- Conditions
- Bladder Cancer, Circulating Tumor Cells
- Being tested
- Detection of circulating tumor cells in blood samples
- Keywords
- Bladder cancer, Circulating cancer cells
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of circulating tumor cells in blood samplesGenetic
Ficoll based isolation of mononuclear cells from the peripheral blood of patients undergoing radical cystectomy, nucleic acids extraction and, finally, PCR based detection of sequences specific to cytokeratins.
| Study group | Role | What they receive |
|---|---|---|
| Cystectomy patients | Arm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells Receives: Genetic: Detection of circulating tumor cells in blood samples | |
| Healthy volunteers | Arm of healthy subjects not undergoing radical cystectomy providing peripheral blood samples for detection of circulating cancer cells Receives: Genetic: Detection of circulating tumor cells in blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of circulating tumor cells
This outcome measure reflects the exact number of subjects diagnosed with circulating tumor cells within the total population of subjects included in the study
Measured: 8 years
Secondary outcomes (1)
Overall survival
Comparison of overall survival between the population of patients found with circulating tumor cells and those found without circulating tumor cells
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2005
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pagliarulo Vincenzo, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Investigators
- Vincenzo VP Pagliarulo, Urologist, Principal investigator, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345473
- Sponsor's protocol ID
- 4186
- Acronym
- CirCanCell
- Status last verified
- Jan 2015
- First submitted
- 14 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666.
PubMed 11157016Steven K, Poulsen AL. Radical cystectomy and extended pelvic lymphadenectomy: survival of patients with lymph node metastasis above the bifurcation of the common iliac vessels treated with surgery only. J Urol. 2007 Oct;178(4 Pt 1):1218-23; discussion 1223-4. doi: 10.1016/j.juro.2007.05.160. Epub 2007 Aug 14.
PubMed 17698113Madersbacher S, Hochreiter W, Burkhard F, Thalmann GN, Danuser H, Markwalder R, Studer UE. Radical cystectomy for bladder cancer today--a homogeneous series without neoadjuvant therapy. J Clin Oncol. 2003 Feb 15;21(4):690-6. doi: 10.1200/JCO.2003.05.101.
PubMed 12586807Lotan Y, Gupta A, Shariat SF, Palapattu GS, Vazina A, Karakiewicz PI, Bastian PJ, Rogers CG, Amiel G, Perotte P, Schoenberg MP, Lerner SP, Sagalowsky AI. Lymphovascular invasion is independently associated with overall survival, cause-specific survival, and local and distant recurrence in patients with negative lymph nodes at radical cystectomy. J Clin Oncol. 2005 Sep 20;23(27):6533-9. doi: 10.1200/JCO.2005.05.516. Epub 2005 Aug 22.
PubMed 16116151Attard G, Swennenhuis JF, Olmos D, Reid AH, Vickers E, A'Hern R, Levink R, Coumans F, Moreira J, Riisnaes R, Oommen NB, Hawche G, Jameson C, Thompson E, Sipkema R, Carden CP, Parker C, Dearnaley D, Kaye SB, Cooper CS, Molina A, Cox ME, Terstappen LW, de Bono JS. Characterization of ERG, AR and PTEN gene status in circulating tumor cells from patients with castration-resistant prostate cancer. Cancer Res. 2009 Apr 1;69(7):2912-8. doi: 10.1158/0008-5472.CAN-08-3667.
PubMed 19339269Marrinucci D, Bethel K, Bruce RH, Curry DN, Hsieh B, Humphrey M, Krivacic RT, Kroener J, Kroener L, Ladanyi A, Lazarus NH, Nieva J, Kuhn P. Case study of the morphologic variation of circulating tumor cells. Hum Pathol. 2007 Mar;38(3):514-9. doi: 10.1016/j.humpath.2006.08.027. Epub 2006 Dec 22.
PubMed 17188328Desgrandchamps F, Teren M, Dal Cortivo L, Marolleau JP, Bertheau P, Villette JM, Cortesse A, Teillac P, Le Duc A, Hamdy FC. The effects of transurethral resection and cystoprostatectomy on dissemination of epithelial cells in the circulation of patients with bladder cancer. Br J Cancer. 1999 Nov;81(5):832-4. doi: 10.1038/sj.bjc.6690771.
PubMed 10555753Osman I, Kang M, Lee A, Deng FM, Polsky D, Mikhail M, Chang C, David DA, Mitra N, Wu XR, Sun TT, Bajorin DF. Detection of circulating cancer cells expressing uroplakins and epidermal growth factor receptor in bladder cancer patients. Int J Cancer. 2004 Oct 10;111(6):934-9. doi: 10.1002/ijc.20366.
PubMed 15300806Ribal MJ, Mengual L, Marin M, Algaba F, Ars E, Fernandez PL, Oliva R, Villavicencio H, Alcaraz A. Molecular staging of bladder cancer with RT-PCR assay for CK20 in peripheral blood, bone marrow and lymph nodes: comparison with standard histological staging. Anticancer Res. 2006 Jan-Feb;26(1A):411-9.
PubMed 16475726Jiang J, Ulbright TM, Younger C, Sanchez K, Bostwick DG, Koch MO, Eble JN, Cheng L. Cytokeratin 7 and cytokeratin 20 in primary urinary bladder carcinoma and matched lymph node metastasis. Arch Pathol Lab Med. 2001 Jul;125(7):921-3. doi: 10.5858/2001-125-0921-CACIPU.
PubMed 11419977Chu P, Wu E, Weiss LM. Cytokeratin 7 and cytokeratin 20 expression in epithelial neoplasms: a survey of 435 cases. Mod Pathol. 2000 Sep;13(9):962-72. doi: 10.1038/modpathol.3880175.
PubMed 11007036Wu XR, Lin JH, Walz T, Haner M, Yu J, Aebi U, Sun TT. Mammalian uroplakins. A group of highly conserved urothelial differentiation-related membrane proteins. J Biol Chem. 1994 May 6;269(18):13716-24.
PubMed 8175808Wu X, Kakehi Y, Zeng Y, Taoka R, Tsunemori H, Inui M. Uroplakin II as a promising marker for molecular diagnosis of nodal metastases from bladder cancer: comparison with cytokeratin 20. J Urol. 2005 Dec;174(6):2138-42, discussion 2142-3. doi: 10.1097/01.ju.0000181214.32390.75.
PubMed 16280744Sawabata N, Okumura M, Utsumi T, Inoue M, Shiono H, Minami M, Nishida T, Sawa Y. Circulating tumor cells in peripheral blood caused by surgical manipulation of non-small-cell lung cancer: pilot study using an immunocytology method. Gen Thorac Cardiovasc Surg. 2007 May;55(5):189-92. doi: 10.1007/s11748-007-0101-2.
PubMed 17554991
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02345473
- Acronym / sponsor ID
- CirCanCell / 4186
- Conditions
- Bladder Cancer, Circulating Tumor Cells
- Keywords
- Bladder cancer, Circulating cancer cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Jan 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.
Very few factors may be identified as prognostic for patients with bladder cancer undergoing radical cystectomy. Recently, detection of circulating tumor cells has shown to be very promising in anticipating both the likelyhood of distant metastases and survival in patients with breast cancer, melanoma, prostate cancer and other malignancies. In the present study we both tested the detection rate of circulating tumor cells using a PCR based methodology in the peripheral blood of patients undergoing radical cystectomy, and we further correlated our results with their clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystectomy patients | – | Genetic: Detection of circulating tumor cells in blood samplesArm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells |
| Healthy volunteers | – | Genetic: Detection of circulating tumor cells in blood samplesArm of healthy subjects not undergoing radical cystectomy providing peripheral blood samples for detection of circulating cancer cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radical cystectomy for bladder cancer and healthy volunteers
Key inclusion criteria (5 listed)
- Prior trans urethral resection of the bladder (TUR)
- Histological confirmation of a transitional cell carcinoma (TCC) of the bladder
- ECOG Performance Status ≤ 2
- WBC count ≥4,000/μL; platelet count ≥150,000/μL; creatinine ≤1.8 mg/dL; AST, ALT, and alkaline phosphatase ≤2X the upper limit of normal, normal total bilirubin
- recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
Key exclusion criteria (4 listed)
- Neo-adjuvant chemotherapy (either planned or already performed)
- Patients receiving investigational medications
- Subjects not suitable for a radical cystectomy
- Patients not willing to participate
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 |
|---|---|---|
| Detection of circulating tumor cells in blood samplesFicoll based isolation of mononuclear cells from the peripheral blood of patients undergoing radical cystectomy, nucleic acids extraction and, finally, PCR based detection of sequences specific to cytokeratins. | Genetic | Cystectomy patients, Healthy volunteers |
Primary outcome
Prevalence of circulating tumor cells
Time frame: 8 years
This outcome measure reflects the exact number of subjects diagnosed with circulating tumor cells within the total population of subjects included in the study
1 secondary outcome
Overall survival
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Background: PubMed 11157016Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75. doi: 10.1200/JCO.2001.19.3.666.
- Background: PubMed 17698113Steven K, Poulsen AL. Radical cystectomy and extended pelvic lymphadenectomy: survival of patients with lymph node metastasis above the bifurcation of the common iliac vessels treated with surgery only. J Urol. 2007 Oct;178(4 Pt 1):1218-23; discussion 1223-4. doi: 10.1016/j.juro.2007.05.160. Epub 2007 Aug 14.
- Background: PubMed 12586807Madersbacher S, Hochreiter W, Burkhard F, Thalmann GN, Danuser H, Markwalder R, Studer UE. Radical cystectomy for bladder cancer today--a homogeneous series without neoadjuvant therapy. J Clin Oncol. 2003 Feb 15;21(4):690-6. doi: 10.1200/JCO.2003.05.101.
- Background: PubMed 16116151Lotan Y, Gupta A, Shariat SF, Palapattu GS, Vazina A, Karakiewicz PI, Bastian PJ, Rogers CG, Amiel G, Perotte P, Schoenberg MP, Lerner SP, Sagalowsky AI. Lymphovascular invasion is independently associated with overall survival, cause-specific survival, and local and distant recurrence in patients with negative lymph nodes at radical cystectomy. J Clin Oncol. 2005 Sep 20;23(27):6533-9. doi: 10.1200/JCO.2005.05.516. Epub 2005 Aug 22.
- Background: PubMed 19339269Attard G, Swennenhuis JF, Olmos D, Reid AH, Vickers E, A'Hern R, Levink R, Coumans F, Moreira J, Riisnaes R, Oommen NB, Hawche G, Jameson C, Thompson E, Sipkema R, Carden CP, Parker C, Dearnaley D, Kaye SB, Cooper CS, Molina A, Cox ME, Terstappen LW, de Bono JS. Characterization of ERG, AR and PTEN gene status in circulating tumor cells from patients with castration-resistant prostate cancer. Cancer Res. 2009 Apr 1;69(7):2912-8. doi: 10.1158/0008-5472.CAN-08-3667.
- Background: PubMed 17188328Marrinucci D, Bethel K, Bruce RH, Curry DN, Hsieh B, Humphrey M, Krivacic RT, Kroener J, Kroener L, Ladanyi A, Lazarus NH, Nieva J, Kuhn P. Case study of the morphologic variation of circulating tumor cells. Hum Pathol. 2007 Mar;38(3):514-9. doi: 10.1016/j.humpath.2006.08.027. Epub 2006 Dec 22.
- Background: PubMed 10555753Desgrandchamps F, Teren M, Dal Cortivo L, Marolleau JP, Bertheau P, Villette JM, Cortesse A, Teillac P, Le Duc A, Hamdy FC. The effects of transurethral resection and cystoprostatectomy on dissemination of epithelial cells in the circulation of patients with bladder cancer. Br J Cancer. 1999 Nov;81(5):832-4. doi: 10.1038/sj.bjc.6690771.
- Background: PubMed 15300806Osman I, Kang M, Lee A, Deng FM, Polsky D, Mikhail M, Chang C, David DA, Mitra N, Wu XR, Sun TT, Bajorin DF. Detection of circulating cancer cells expressing uroplakins and epidermal growth factor receptor in bladder cancer patients. Int J Cancer. 2004 Oct 10;111(6):934-9. doi: 10.1002/ijc.20366.
- Background: PubMed 16475726Ribal MJ, Mengual L, Marin M, Algaba F, Ars E, Fernandez PL, Oliva R, Villavicencio H, Alcaraz A. Molecular staging of bladder cancer with RT-PCR assay for CK20 in peripheral blood, bone marrow and lymph nodes: comparison with standard histological staging. Anticancer Res. 2006 Jan-Feb;26(1A):411-9.
- Background: PubMed 11419977Jiang J, Ulbright TM, Younger C, Sanchez K, Bostwick DG, Koch MO, Eble JN, Cheng L. Cytokeratin 7 and cytokeratin 20 in primary urinary bladder carcinoma and matched lymph node metastasis. Arch Pathol Lab Med. 2001 Jul;125(7):921-3. doi: 10.5858/2001-125-0921-CACIPU.
- Background: PubMed 11007036Chu P, Wu E, Weiss LM. Cytokeratin 7 and cytokeratin 20 expression in epithelial neoplasms: a survey of 435 cases. Mod Pathol. 2000 Sep;13(9):962-72. doi: 10.1038/modpathol.3880175.
- Background: PubMed 8175808Wu XR, Lin JH, Walz T, Haner M, Yu J, Aebi U, Sun TT. Mammalian uroplakins. A group of highly conserved urothelial differentiation-related membrane proteins. J Biol Chem. 1994 May 6;269(18):13716-24.
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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.
Vincenzo VP Pagliarulo, Urologist principal investigator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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 Bladder Cancer and Circulating Tumor Cells, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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: finished, as of the sponsor's last update on 26 Jan 2015. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of circulating tumor cells (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02345473, which also lists 14 linked publications.
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 26 Jan 2015.