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CompletedNCT02345473CirCanCellUpdated Jan 26, 2015

Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy

An observational study in Bladder Cancer and Circulating Tumor Cells, sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
59
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Bladder Cancer
  • Circulating Tumor Cells

Keywords

  • Bladder cancer
  • Circulating cancer cells
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 59 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari is the lead sponsor of 44 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients undergoing radical cystectomy for bladder cancer and healthy volunteers

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Neo-adjuvant chemotherapy (either planned or already performed)
  • Patients receiving investigational medications
  • Subjects not suitable for a radical cystectomy
  • Patients not willing to participate
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
59 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cystectomy patients

    Arm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells

    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

    Genetic: Detection of circulating tumor cells in blood samples

Interventions

  • GeneticDetection of circulating tumor cells in blood samples

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 8 years

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Study locations

1 site
  • Vincenzo Pagliarulo
    Bari, 70124, Italy
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References and documents

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 11157016 ↗
  • Steven 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 17698113 ↗
  • Madersbacher 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 12586807 ↗
  • Lotan 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 16116151 ↗
  • Attard 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 19339269 ↗
  • Marrinucci 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 17188328 ↗
  • Desgrandchamps 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 10555753 ↗
  • Osman 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 15300806 ↗
  • Ribal 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 16475726 ↗
  • Jiang 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 11419977 ↗
  • Chu 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 11007036 ↗
  • Wu 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 8175808 ↗
  • Wu 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 16280744 ↗
  • Sawabata 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02345473
Lead sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Responsible party
Pagliarulo Vincenzo (Medical Doctor, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari) — Principal investigator
First posted
Jan 26, 2015
Start date
Jan 2005
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Jan 26, 2015

Study contacts

Vincenzo VP Pagliarulo, Urologist
principal investigator · Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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