Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)

Collecting Duct Carcinoma Clinical Trial

— CICERONE  

Official title:

Collecting Ducts Carcinoma: in Depth Exploration and Biologically Driven Therapy (CICERONE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372302
• Other study ID #: INT 12/21
• Status: Recruiting
• Start date: July 8, 2021
• Est. completion date: October 2022

Study information

• Verified date: May 2022
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Elena Verzoni, MD
• Phone: 0223904449
• Email: elena.verzoni[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

- Collect a large number of samples with certain / suspected diagnosis of collecting duct carcinoma in order to confirm the diagnosis (centralized review) and standardize according to WHO 2016 criteria - Build an extensive tissue bank (DNA and RNA extraction) aimed at defining the molecular taxonomy of the tumor through 1) transcriptomic analysis 2) gene expression profile - Define specific molecular signatures

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age = 18 years
• Signature of consent (for patients enrolled in the prospective part of the study)
• Histological diagnosis of renal cell carcinoma of the Bellini collecting duct RCC Exclusion Criteria: -

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ductal
• Carcinoma, Renal Cell
• Collecting Duct Carcinoma

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (21)

Becker F, Junker K, Parr M, Hartmann A, Füssel S, Toma M, Grobholz R, Pflugmann T, Wullich B, Strauss A, Behnes CL, Otto W, Stöckle M, Jung V. Collecting duct carcinomas represent a unique tumor entity based on genetic alterations. PLoS One. 2013 Oct 22;8(10):e78137. doi: 10.1371/journal.pone.0078137. eCollection 2013. — View Citation

Cherkasova E, Scrivani C, Doh S, Weisman Q, Takahashi Y, Harashima N, Yokoyama H, Srinivasan R, Linehan WM, Lerman MI, Childs RW. Detection of an Immunogenic HERV-E Envelope with Selective Expression in Clear Cell Kidney Cancer. Cancer Res. 2016 Apr 15;76(8):2177-85. doi: 10.1158/0008-5472.CAN-15-3139. Epub 2016 Feb 9. — View Citation

Dobin A, Davis CA, Schlesinger F, Drenkow J, Zaleski C, Jha S, Batut P, Chaisson M, Gingeras TR. STAR: ultrafast universal RNA-seq aligner. Bioinformatics. 2013 Jan 1;29(1):15-21. doi: 10.1093/bioinformatics/bts635. Epub 2012 Oct 25. — View Citation

E. Verzoni, L. De Cecco, M. Dugo, D. Rinchai, D. Bedognetti, P. Grassi, R. Ratta, A. Cova, P. Squarcina, V. Huber, R. Montone, M. Sorrentino, G. Procopio, L. Rivoltini. Broad immunomodulating effect of first-line Pazopanib in metastatic renal cell carcinoma patients. Annals of Oncology (2017) 28 (suppl_5): v295-v329.

E. Verzoni, S. Ferro, G. Procopio, A. Cova, R. Ratta, A. Raimondi, P. Sepe, P. Squarcina, L. Lalli, V. Huber, D. Rinchai, D. Bedognetti, L. Rivoltini. Potent Natural Killer (NK) and myeloid blood cell remodeling by Cabozantinib (Cabo) in pretreated metastatic renal cell carcinoma (mRCC) patients (pts). Annals of Oncology (2018) 29 (suppl_8): viii303-viii331.

Filipazzi P, Valenti R, Huber V, Pilla L, Canese P, Iero M, Castelli C, Mariani L, Parmiani G, Rivoltini L. Identification of a new subset of myeloid suppressor cells in peripheral blood of melanoma patients with modulation by a granulocyte-macrophage colony-stimulation factor-based antitumor vaccine. J Clin Oncol. 2007 Jun 20;25(18):2546-53. — View Citation

G.Procopio, R. Ratta, G. Fucà, P. Grassi, L. Porcu, M. Prisciandaro, G. Calareso, R. Montone, M. Sorrentino, E. Verzoni. A phase 2 study of cabozantinib as first-line treatment in collecting ducts renal cell carcinoma: The BONSAI trial. J Clin Oncol 36, 2018.DOI:10.1200/JCO.2018.36.6_suppl.TPS709

Gupta R, Billis A, Shah RB, Moch H, Osunkoya AO, Jochum W, Hes O, Bacchi CE, de Castro MG, Hansel DE, Zhou M, Vankalakunti M, Salles PG, Cabrera RA, Gown AM, Amin MB. Carcinoma of the collecting ducts of Bellini and renal medullary carcinoma: clinicopathologic analysis of 52 cases of rare aggressive subtypes of renal cell carcinoma with a focus on their interrelationship. Am J Surg Pathol. 2012 Sep;36(9):1265-78. — View Citation

Huber V, Vallacchi V, Fleming V, Hu X, Cova A, Dugo M, Shahaj E, Sulsenti R, Vergani E, Filipazzi P, De Laurentiis A, Lalli L, Di Guardo L, Patuzzo R, Vergani B, Casiraghi E, Cossa M, Gualeni A, Bollati V, Arienti F, De Braud F, Mariani L, Villa A, Altevogt P, Umansky V, Rodolfo M, Rivoltini L. Tumor-derived microRNAs induce myeloid suppressor cells and predict immunotherapy resistance in melanoma. J Clin Invest. 2018 Dec 3;128(12):5505-5516. doi: 10.1172/JCI98060. Epub 2018 Nov 5. — View Citation

Liu L, Miao L, Liu Y, Qi A, Xie P, Chen J, Zhu H. S100A11 regulates renal carcinoma cell proliferation, invasion, and migration via the EGFR/Akt signaling pathway and E-cadherin. Tumour Biol. 2017 May;39(5):1010428317705337. doi: 10.1177/1010428317705337. — View Citation

Malouf GG, Compérat E, Yao H, Mouawad R, Lindner V, Rioux-Leclercq N, Verkarre V, Leroy X, Dainese L, Classe M, Descotes JL, Barthelemy P, Yacoub M, Rouprêt M, Bernhard JC, Creighton CJ, Spano JP, Su X, Khayat D. Unique Transcriptomic Profile of Collecting Duct Carcinomas Relative to Upper Tract Urothelial Carcinomas and other Kidney Carcinomas. Sci Rep. 2016 Aug 3;6:30988. doi: 10.1038/srep30988. — View Citation

McDermott DF, Huseni MA, Atkins MB, Motzer RJ, Rini BI, Escudier B, Fong L, Joseph RW, Pal SK, Reeves JA, Sznol M, Hainsworth J, Rathmell WK, Stadler WM, Hutson T, Gore ME, Ravaud A, Bracarda S, Suárez C, Danielli R, Gruenwald V, Choueiri TK, Nickles D, Jhunjhunwala S, Piault-Louis E, Thobhani A, Qiu J, Chen DS, Hegde PS, Schiff C, Fine GD, Powles T. Clinical activity and molecular correlates of response to atezolizumab alone or in combination with bevacizumab versus sunitinib in renal cell carcinoma. Nat Med. 2018 Jun;24(6):749-757. doi: 10.1038/s41591-018-0053-3. Epub 2018 Jun 4. Erratum in: Nat Med. 2018 Dec;24(12):1941. — View Citation

Pagani F, Colecchia M, Sepe P, Apollonio G, Claps M, Verzoni E, de Braud F, Procopio G. Collecting ducts carcinoma: An orphan disease. Literature overview and future perspectives. Cancer Treat Rev. 2019 Sep;79:101891. doi: 10.1016/j.ctrv.2019.101891. Epub 2019 Aug 27. Review. — View Citation

Pal SK, Choueiri TK, Wang K, Khaira D, Karam JA, Van Allen E, Palma NA, Stein MN, Johnson A, Squillace R, Elvin JA, Chmielecki J, Yelensky R, Yakirevich E, Lipson D, Lin DI, Miller VA, Stephens PJ, Ali SM, Ross JS. Characterization of Clinical Cases of Collecting Duct Carcinoma of the Kidney Assessed by Comprehensive Genomic Profiling. Eur Urol. 2016 Sep;70(3):516-21. doi: 10.1016/j.eururo.2015.06.019. Epub 2015 Jul 3. — View Citation

Paquet ER, Hallett MT. Absolute assignment of breast cancer intrinsic molecular subtype. J Natl Cancer Inst. 2014 Dec 4;107(1):357. doi: 10.1093/jnci/dju357. Print 2015 Jan. — View Citation

Procopio G, Sepe P, Claps M, Buti S, Colecchia M, Giannatempo P, Guadalupi V, Mariani L, Lalli L, Fucà G, de Braud F, Verzoni E. Cabozantinib as First-line Treatment in Patients With Metastatic Collecting Duct Renal Cell Carcinoma: Results of the BONSAI Trial for the Italian Network for Research in Urologic-Oncology (Meet-URO 2 Study). JAMA Oncol. 2022 Apr 14. doi: 10.1001/jamaoncol.2022.0238. [Epub ahead of print] — View Citation

Procopio G, Testa I, Iacovelli R, Grassi P, Verzoni E, Garanzini E, Colecchia M, Torelli T, De Braud F. Treatment of collecting duct carcinoma: current status and future perspectives. Anticancer Res. 2014 Feb;34(2):1027-30. — View Citation

Procopio G, Verzoni E, Iacovelli R, Colecchia M, Torelli T, Mariani L. Is there a role for targeted therapies in the collecting ducts of Bellini carcinoma? Efficacy data from a retrospective analysis of 7 cases. Clin Exp Nephrol. 2012 Jun;16(3):464-7. doi: 10.1007/s10157-012-0589-3. Epub 2012 Jan 26. — View Citation

Selli C, Amorosi A, Vona G, Sestini R, Travaglini F, Bartoletti R, Orlando C. Retrospective evaluation of c-erbB-2 oncogene amplification using competitive PCR in collecting duct carcinoma of the kidney. J Urol. 1997 Jul;158(1):245-7. — View Citation

Tokuda N, Naito S, Matsuzaki O, Nagashima Y, Ozono S, Igarashi T; Japanese Society of Renal Cancer. Collecting duct (Bellini duct) renal cell carcinoma: a nationwide survey in Japan. J Urol. 2006 Jul;176(1):40-3; discussion 43. — View Citation

Wang J, Papanicolau-Sengos A, Chintala S, Wei L, Liu B, Hu Q, Miles KM, Conroy JM, Glenn ST, Costantini M, Magi-Galluzzi C, Signoretti S, Choueiri T, Gallucci M, Sentinelli S, Fazio VM, Poeta ML, Liu S, Morrison C, Pili R. Collecting duct carcinoma of the kidney is associated with CDKN2A deletion and SLC family gene up-regulation. Oncotarget. 2016 May 24;7(21):29901-15. doi: 10.18632/oncotarget.9093. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	samples to confirm and standardize	Collect a large number of samples with certain / suspected diagnosis of collecting duct carcinoma in order to confirm the diagnosis (centralized review) and standardize it according to WHO 2016 criteria	15 month
Secondary	Tissue Bank	Build an extensive tissue bank (DNA and RNA extraction) aimed at defining the molecular taxonomy of the tumor through 1) transcriptomic analysis 2) gene expression profile	15 month
Secondary	specific molecular signatures	Define specific molecular signatures	15 month