Urogenital Neoplasms Clinical Trial
— AvatarOfficial title:
Potential Therapeutic Response In Urogenital Tumors: Ex-Ovo Avian Embryo Patient Avatar
NCT number | NCT03551457 |
Other study ID # | AVATAR |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2, 2019 |
Est. completion date | May 16, 2022 |
Verified date | July 2022 |
Source | University of Campinas, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 16, 2022 |
Est. primary completion date | January 4, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Urogenital neoplasm - Undergo biopsy Exclusion Criteria: - Not accept to participate |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas Unicamp | Campinas | SP |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
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. — View Citation
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. — View Citation
Dohle DS, Pasa SD, Gustmann S, Laub M, Wissler JH, Jennissen HP, Dünker N. Chick ex ovo culture and ex ovo CAM assay: how it really works. J Vis Exp. 2009 Nov 30;(33). pii: 1620. doi: 10.3791/1620. — View Citation
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, Röelli 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. — View Citation
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. Epub 2005 Jan 21. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - Therapeutic tumor response phenotype | drug sensitivity | 7 days | |
Secondary | - Platform efficiency | tumor take in percentage | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00377520 -
A Trial for Patients With Advanced/Recurrent Endometrial Cancer
|
Phase 2 | |
Recruiting |
NCT04462926 -
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
|
N/A | |
Active, not recruiting |
NCT03344757 -
Health Gatherings - For Your Health After Cancer
|
N/A | |
Recruiting |
NCT04566952 -
Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT03562897 -
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
|
Phase 2 | |
Recruiting |
NCT04923178 -
A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
|
||
Terminated |
NCT02543645 -
A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer
|
Phase 1 | |
Terminated |
NCT04221828 -
Trial of NanoPac Focal Therapy for Prostate Cancer
|
Phase 2 | |
Not yet recruiting |
NCT05030077 -
Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma
|
Phase 2 | |
Recruiting |
NCT04556071 -
Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT01523652 -
Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients
|
N/A | |
Completed |
NCT04679675 -
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
|
N/A | |
Terminated |
NCT02386111 -
A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma
|
Phase 1 | |
Completed |
NCT03081858 -
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04644432 -
Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT04811846 -
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
|
N/A | |
Completed |
NCT04435964 -
Gender Difference in sidE eFfects of ImmuNotherapy: a Possible Clue to Optimize cancEr tReatment
|
||
Recruiting |
NCT04922047 -
Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)
|
Phase 1/Phase 2 | |
Terminated |
NCT01918605 -
Protection of Rectum From High Radiation Doses Using a Spacer
|
N/A | |
Completed |
NCT01316458 -
Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy
|
Phase 2 |