Potential Therapeutic Response In Urogenital Tumors

NCT03551457 | Completed DMC

• 1 other identifier: AVATAR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Preclinical models of urogenital carcinoma have been emerging as a way to pre-determine drug resistance before therapy is targeted. The implantation of tumor specimens in the chorioallantoic membrane (CAM) of the chicken embryo results in a high-efficiency graft, thus allowing large-scale studies of "tumor avatar". The aim of the study is to develop a tumor culture platform for treatment evaluation. Biopsies will be collected from primary tumors of patients and grafted onto the chorioallantoic membrane of chicken embryos. After tumor implantation at the CAM, tumor growth will be accompanied by imaging that will quantify tumor vascularization, tumor volume, and tumor blood flow. Following tumor growth, "avatars" will be divided into different treatments. Using the "tumor avatar" model together with patient tumors, the investigators will be able to observe the individualized tumor response for each patient in a treatment context, as well as determine the potential drug to be used in each case. These results may support a phenotype-based reading within 7-10 days.

Conditions

Urogenital Neoplasms; Drug Therapy

Keywords

Patient Derived Xenograft; Treatment Response Phenotype; Personalised

Outcome Measures

Primary Outcomes (1)

• - Therapeutic tumor response phenotype

  drug sensitivity

  7 days

Secondary Outcomes (1)

• - Platform efficiency

  7 days

Interventions

Biopsy DIAGNOSTIC_TEST

Patient-derived xenograft treatment response phenotype.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients diagnosed with urogenital neoplasms, submitted to tumor ressection.

You may qualify if:

• Urogenital neoplasm
• Undergo biopsy

You may not qualify if:

• Not accept to participate

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Hospital das Clínicas Unicamp

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (7)

• Chia S, Low JL, Zhang X, Kwang XL, Chong FT, Sharma A, Bertrand D, Toh SY, Leong HS, Thangavelu MT, Hwang JSG, Lim KH, Skanthakumar T, Tan HK, Su Y, Hui Choo S, Hentze H, Tan IBH, Lezhava A, Tan P, Tan DSW, Periyasamy G, Koh JLY, Gopalakrishna Iyer N, DasGupta R. Phenotype-driven precision oncology as a guide for clinical decisions one patient at a time. Nat Commun. 2017 Sep 5;8(1):435. doi: 10.1038/s41467-017-00451-5.

  PMID: 28874669 BACKGROUND

• Dohle DS, Pasa SD, Gustmann S, Laub M, Wissler JH, Jennissen HP, Dunker N. Chick ex ovo culture and ex ovo CAM assay: how it really works. J Vis Exp. 2009 Nov 30;(33):1620. doi: 10.3791/1620.

  PMID: 19949373 BACKGROUND

• Gao H, Korn JM, Ferretti S, Monahan JE, Wang Y, Singh M, Zhang C, Schnell C, Yang G, Zhang Y, Balbin OA, Barbe S, Cai H, Casey F, Chatterjee S, Chiang DY, Chuai S, Cogan SM, Collins SD, Dammassa E, Ebel N, Embry M, Green J, Kauffmann A, Kowal C, Leary RJ, Lehar J, Liang Y, Loo A, Lorenzana E, Robert McDonald E 3rd, McLaughlin ME, Merkin J, Meyer R, Naylor TL, Patawaran M, Reddy A, Roelli C, Ruddy DA, Salangsang F, Santacroce F, Singh AP, Tang Y, Tinetto W, Tobler S, Velazquez R, Venkatesan K, Von Arx F, Wang HQ, Wang Z, Wiesmann M, Wyss D, Xu F, Bitter H, Atadja P, Lees E, Hofmann F, Li E, Keen N, Cozens R, Jensen MR, Pryer NK, Williams JA, Sellers WR. High-throughput screening using patient-derived tumor xenografts to predict clinical trial drug response. Nat Med. 2015 Nov;21(11):1318-25. doi: 10.1038/nm.3954. Epub 2015 Oct 19.

  PMID: 26479923 BACKGROUND

• Cully M. Cancer: Xenograft encyclopaedia identifies drug combination opportunities. Nat Rev Drug Discov. 2015 Dec;14(12):818. doi: 10.1038/nrd4788. Epub 2015 Nov 20. No abstract available.

  PMID: 26585532 BACKGROUND

• Hagedorn M, Javerzat S, Gilges D, Meyre A, de Lafarge B, Eichmann A, Bikfalvi A. Accessing key steps of human tumor progression in vivo by using an avian embryo model. Proc Natl Acad Sci U S A. 2005 Feb 1;102(5):1643-8. doi: 10.1073/pnas.0408622102. Epub 2005 Jan 21.

  PMID: 15665100 BACKGROUND

• Izumchenko E, Paz K, Ciznadija D, Sloma I, Katz A, Vasquez-Dunddel D, Ben-Zvi I, Stebbing J, McGuire W, Harris W, Maki R, Gaya A, Bedi A, Zacharoulis S, Ravi R, Wexler LH, Hoque MO, Rodriguez-Galindo C, Pass H, Peled N, Davies A, Morris R, Hidalgo M, Sidransky D. Patient-derived xenografts effectively capture responses to oncology therapy in a heterogeneous cohort of patients with solid tumors. Ann Oncol. 2017 Oct 1;28(10):2595-2605. doi: 10.1093/annonc/mdx416.

  PMID: 28945830 BACKGROUND

• Skowron MA, Sathe A, Romano A, Hoffmann MJ, Schulz WA, van Koeveringe GA, Albers P, Nawroth R, Niegisch G. Applying the chicken embryo chorioallantoic membrane assay to study treatment approaches in urothelial carcinoma. Urol Oncol. 2017 Sep;35(9):544.e11-544.e23. doi: 10.1016/j.urolonc.2017.05.003. Epub 2017 May 25.

  PMID: 28551413 BACKGROUND

MeSH Terms

Conditions

Urogenital Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Leonardo O Reis, MD, MSc, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher MD, MSc, PhD

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: January 2, 2019
• Primary Completion: January 4, 2022
• Study Completion: May 16, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: End of study when data are published.
• Access Criteria: Results shared in a publication.

Locations

BR (1)