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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01339975
Other study ID # CHUBX 2010/45
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 6, 2011
Est. completion date May 2019

Study information

Verified date August 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.

The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.


Description:

Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management.

Therefore the identification of new molecular biomarkers is important:

- to improve the precision of prognostic models currently based on clinical, biological or histopathological variables

- to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up

- to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia

- to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification

Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.


Recruitment information / eligibility

Status Completed
Enrollment 310
Est. completion date May 2019
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma :

- having a radical or partial nephrectomy

- or treated by RCC-directed targeted therapy

- Patients who have signed and dated an informed consent form with the investigator

Exclusion Criteria:

- under 18 years old

Study Design


Intervention

Biological:
Biological sample
2 blood samples of 10mL + one urine sample on pre-operative d-1/d, post-operative d1 and d5(+/-2), one month post-operative, at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises.
Biological sample
2 blood samples of 10mL + one urine sample before starting the therapy at first therapeutic evaluation (2 or 3 months depending on the treatment chosen) at the end of the study or at the date of disease progression.

Locations

Country Name City State
France University Bordeaux Hospital Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (22)

Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinié F, Danzon A, Bara S, Bouvier AM, Trétarre B, Binder-Foucard F, Colonna M, Daubisse L, Hédelin G, Launoy G, Le Stang N, Maynadié M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Chérié-Challine L, Estève J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-75. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10. — View Citation

Bensalah K, Pantuck AJ, Crepel M, Verhoest G, Méjean A, Valéri A, Ficarra V, Pfister C, Ferrière JM, Soulié M, Cindolo L, De La Taille A, Tostain J, Chautard D, Schips L, Zigeuner R, Abbou CC, Lobel B, Salomon L, Lechevallier E, Descotes JL, Guillé F, Colombel M, Belldegrun AS, Patard JJ. Prognostic variables to predict cancer-related death in incidental renal tumours. BJU Int. 2008 Nov;102(10):1376-80. doi: 10.1111/j.1464-410X.2008.07847.x. Epub 2008 Aug 22. — View Citation

Eisman R, Surrey S, Ramachandran B, Schwartz E, Poncz M. Structural and functional comparison of the genes for human platelet factor 4 and PF4alt. Blood. 1990 Jul 15;76(2):336-44. — View Citation

Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203. — View Citation

Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22;370(9605):2103-11. — View Citation

Furniss D, Harnden P, Ali N, Royston P, Eisen T, Oliver RT, Hancock BW; National Cancer Research Institute Renal Clinical Studies Group. Prognostic factors for renal cell carcinoma. Cancer Treat Rev. 2008 Aug;34(5):407-26. doi: 10.1016/j.ctrv.2007.12.008. Epub 2008 Apr 28. Review. — View Citation

Jouan V, Canron X, Alemany M, Caen JP, Quentin G, Plouet J, Bikfalvi A. Inhibition of in vitro angiogenesis by platelet factor-4-derived peptides and mechanism of action. Blood. 1999 Aug 1;94(3):984-93. — View Citation

Kattan MW, Reuter V, Motzer RJ, Katz J, Russo P. A postoperative prognostic nomogram for renal cell carcinoma. J Urol. 2001 Jul;166(1):63-7. — View Citation

Klatte T, Seligson DB, Leppert JT, Riggs SB, Yu H, Zomorodian N, Kabbinavar FF, Strieter RM, Belldegrun AS, Pantuck AJ. The chemokine receptor CXCR3 is an independent prognostic factor in patients with localized clear cell renal cell carcinoma. J Urol. 2008 Jan;179(1):61-6. Epub 2007 Nov 13. — View Citation

Lasagni L, Francalanci M, Annunziato F, Lazzeri E, Giannini S, Cosmi L, Sagrinati C, Mazzinghi B, Orlando C, Maggi E, Marra F, Romagnani S, Serio M, Romagnani P. An alternatively spliced variant of CXCR3 mediates the inhibition of endothelial cell growth induced by IP-10, Mig, and I-TAC, and acts as functional receptor for platelet factor 4. J Exp Med. 2003 Jun 2;197(11):1537-49. — View Citation

Maione TE, Gray GS, Petro J, Hunt AJ, Donner AL, Bauer SI, Carson HF, Sharpe RJ. Inhibition of angiogenesis by recombinant human platelet factor-4 and related peptides. Science. 1990 Jan 5;247(4938):77-9. — View Citation

Margulis V, Sánchez-Ortiz RF, Tamboli P, Cohen DD, Swanson DA, Wood CG. Renal cell carcinoma clinically involving adjacent organs: experience with aggressive surgical management. Cancer. 2007 May 15;109(10):2025-30. — View Citation

Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. — View Citation

Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002 Jan 1;20(1):289-96. — View Citation

Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. — View Citation

Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. — View Citation

Pan J, Burdick MD, Belperio JA, Xue YY, Gerard C, Sharma S, Dubinett SM, Strieter RM. CXCR3/CXCR3 ligand biological axis impairs RENCA tumor growth by a mechanism of immunoangiostasis. J Immunol. 2006 Feb 1;176(3):1456-64. — View Citation

Ravaud A, Wallerand H, Culine S, Bernhard JC, Fergelot P, Bensalah K, Patard JJ. Update on the medical treatment of metastatic renal cell carcinoma. Eur Urol. 2008 Aug;54(2):315-25. doi: 10.1016/j.eururo.2008.04.056. Epub 2008 May 5. Review. — View Citation

Raynal G, Bernhard JC. [Premature death from urologic cancer: the kidneys at the forefront]. Prog Urol. 2007 Apr;17(2):260-1. French. — View Citation

Struyf S, Burdick MD, Peeters E, Van den Broeck K, Dillen C, Proost P, Van Damme J, Strieter RM. Platelet factor-4 variant chemokine CXCL4L1 inhibits melanoma and lung carcinoma growth and metastasis by preventing angiogenesis. Cancer Res. 2007 Jun 15;67(12):5940-8. — View Citation

Struyf S, Burdick MD, Proost P, Van Damme J, Strieter RM. Platelets release CXCL4L1, a nonallelic variant of the chemokine platelet factor-4/CXCL4 and potent inhibitor of angiogenesis. Circ Res. 2004 Oct 29;95(9):855-7. Epub 2004 Sep 30. — View Citation

Zisman A, Pantuck AJ, Wieder J, Chao DH, Dorey F, Said JW, deKernion JB, Figlin RA, Belldegrun AS. Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol. 2002 Dec 1;20(23):4559-66. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence.
Localized or locally advanced renal cell carcinoma group:
local recurrence
contralateral recurrence
extra-renal distant recurrence (metastatic progression)
specific cancer death
nonspecific cancer death
Metastatic renal cell carcinoma group :
local recurrence for patients who underwent a nephrectomy
contralateral reccurence
metastatic progression
specific cancer death
nonspecific cancer death
3 years
Secondary Predictive value of therapeutic response Predictive value of therapeutic response will be assessed for patients receiving systemic therapy. It will be evaluated by the association of markers of interest with the therapeutic response.
RECIST criteria: patients showing a complete response or a partial response, will be considered as "responders"
The progression of the longest diameter of tumor, the proportion of intra-tumor necrosis (Choi criteria) and +/- the perfusion characteristics of tumor if primitive tumor
3 years
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