Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy (CirCanCell)
19. januar 2015 opdateret af: Pagliarulo Vincenzo, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
59
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bari, Italien, 70124
- Vincenzo Pagliarulo
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients undergoing radical cystectomy for bladder cancer and healthy volunteers
Beskrivelse
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:
- Neo-adjuvant chemotherapy (either planned or already performed)
- Patients receiving investigational medications
- Subjects not suitable for a radical cystectomy
- Patients not willing to participate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Cystectomy patients
Arm of patients undergoing radical cystectomy for bladder cancer providing peripheral blood samples for detection of circulating cancer cells
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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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Healthy volunteers
Arm of healthy subjects not undergoing radical cystectomy providing peripheral blood samples for detection of circulating cancer cells
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of circulating tumor cells
Tidsramme: 8 years
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This outcome measure reflects the exact number of subjects diagnosed with circulating tumor cells within the total population of subjects included in the study
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8 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall survival
Tidsramme: 8 years
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Comparison of overall survival between the population of patients found with circulating tumor cells and those found without circulating tumor cells
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8 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Vincenzo VP Pagliarulo, Urologist, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2005
Primær færdiggørelse (Faktiske)
1. oktober 2014
Studieafslutning (Faktiske)
1. oktober 2014
Datoer for studieregistrering
Først indsendt
14. januar 2015
Først indsendt, der opfyldte QC-kriterier
19. januar 2015
Først opslået (Skøn)
26. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. januar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. januar 2015
Sidst verificeret
1. januar 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4186
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .