NCT04342286

Brief Summary

Kidney cancer is one of the ten most common malignancies, and the incidence is increasing in recent year. From Hong Kong Cancer Registry, there was about 670 new cases diagnosed in 2016, and had been increased by 46% compared to 2007.Within the broad classification of kidney cancers, renal cell carcinoma (RCC) accounts for approximately 85% of all cases and greater than 90% of all renal malignancies. Despite the improved understanding and also diagnosis for kidney cancer, still about one fourth of patients will presented at metastatic stage or developed recurrence after initial treatment and required further systemic therapy. Facing the wide range of available options for systemic therapy, the current challenge is how to select the most effective treatment. Unfortunately, there is no good biomarkers available to aid treatment selection. Currently, there are some approaches to try to test the response of kidney cancer to different chemotherapeutic agents. Previous studies showed that 3D organoid culture model can improve our ability to model tumor behavior. Organoid culture technology may provide opportunities for new drug development and drug screening. In this study, investigators aim to establish a reliable and effective method to cultivate kidney cancer cells, then will provide researchers for further information on personalized and targeted therapy on kidney cancer for local Hong Kong patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

10 months

First QC Date

April 8, 2020

Last Update Submit

December 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • To establish a sustainable human kidney tumor 3D Matrigel culture system with a stable phenotype

    A Cell culture is successful when organoids grow from dividing cells

    2 years

Secondary Outcomes (2)

  • The identicality of histopathological detail and genomic information of the kidney cancer organoid compared with the original primary tissue

    2 years

  • The tumorigenicity ability of the kidney cancer organoid in nude mice

    2 years

Interventions

Organoid culture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a methodology development project aiming at developing a reproducible 3D kidney cancer organoid model. Twenty patients suffered from renal cell carcinoma and planned for surgical treatment will be recruited for this study.

You may qualify if:

  • Male patients \> 18 years old
  • Patients suffered from renal cell carcinoma require surgical removal of kidney

You may not qualify if:

  • Patients fail to provide informed consent
  • The collection of tissue will affect the pathological interpretation of the specimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (14)

  • Mer AS, Ba-Alawi W, Smirnov P, Wang YX, Brew B, Ortmann J, Tsao MS, Cescon DW, Goldenberg A, Haibe-Kains B. Integrative Pharmacogenomics Analysis of Patient-Derived Xenografts. Cancer Res. 2019 Sep 1;79(17):4539-4550. doi: 10.1158/0008-5472.CAN-19-0349. Epub 2019 May 29.

    PMID: 31142512BACKGROUND
  • Batchelder CA, Martinez ML, Duru N, Meyers FJ, Tarantal AF. Three Dimensional Culture of Human Renal Cell Carcinoma Organoids. PLoS One. 2015 Aug 28;10(8):e0136758. doi: 10.1371/journal.pone.0136758. eCollection 2015.

    PMID: 26317980BACKGROUND
  • Alley MC, Scudiero DA, Monks A, Hursey ML, Czerwinski MJ, Fine DL, Abbott BJ, Mayo JG, Shoemaker RH, Boyd MR. Feasibility of drug screening with panels of human tumor cell lines using a microculture tetrazolium assay. Cancer Res. 1988 Feb 1;48(3):589-601.

    PMID: 3335022BACKGROUND
  • Drost J, Karthaus WR, Gao D, Driehuis E, Sawyers CL, Chen Y, Clevers H. Organoid culture systems for prostate epithelial and cancer tissue. Nat Protoc. 2016 Feb;11(2):347-58. doi: 10.1038/nprot.2016.006. Epub 2016 Jan 21.

    PMID: 26797458BACKGROUND
  • 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: 26479923BACKGROUND
  • Huch M, Gehart H, van Boxtel R, Hamer K, Blokzijl F, Verstegen MM, Ellis E, van Wenum M, Fuchs SA, de Ligt J, van de Wetering M, Sasaki N, Boers SJ, Kemperman H, de Jonge J, Ijzermans JN, Nieuwenhuis EE, Hoekstra R, Strom S, Vries RR, van der Laan LJ, Cuppen E, Clevers H. Long-term culture of genome-stable bipotent stem cells from adult human liver. Cell. 2015 Jan 15;160(1-2):299-312. doi: 10.1016/j.cell.2014.11.050. Epub 2014 Dec 18.

    PMID: 25533785BACKGROUND
  • Li M, Izpisua Belmonte JC. Organoids - Preclinical Models of Human Disease. N Engl J Med. 2019 Feb 7;380(6):569-579. doi: 10.1056/NEJMra1806175. No abstract available.

    PMID: 30726695BACKGROUND
  • Li YY, Chung GT, Lui VW, To KF, Ma BB, Chow C, Woo JK, Yip KY, Seo J, Hui EP, Mak MK, Rusan M, Chau NG, Or YY, Law MH, Law PP, Liu ZW, Ngan HL, Hau PM, Verhoeft KR, Poon PH, Yoo SK, Shin JY, Lee SD, Lun SW, Jia L, Chan AW, Chan JY, Lai PB, Fung CY, Hung ST, Wang L, Chang AM, Chiosea SI, Hedberg ML, Tsao SW, van Hasselt AC, Chan AT, Grandis JR, Hammerman PS, Lo KW. Exome and genome sequencing of nasopharynx cancer identifies NF-kappaB pathway activating mutations. Nat Commun. 2017 Jan 18;8:14121. doi: 10.1038/ncomms14121.

    PMID: 28098136BACKGROUND
  • McKay RR, Bosse D, Choueiri TK. Evolving Systemic Treatment Landscape for Patients With Advanced Renal Cell Carcinoma. J Clin Oncol. 2018 Oct 29:JCO2018790253. doi: 10.1200/JCO.2018.79.0253. Online ahead of print.

    PMID: 30372392BACKGROUND
  • Meijer TG, Naipal KA, Jager A, van Gent DC. Ex vivo tumor culture systems for functional drug testing and therapy response prediction. Future Sci OA. 2017 Mar 27;3(2):FSO190. doi: 10.4155/fsoa-2017-0003. eCollection 2017 Jun.

    PMID: 28670477BACKGROUND
  • Morizane R, Bonventre JV. Kidney Organoids: A Translational Journey. Trends Mol Med. 2017 Mar;23(3):246-263. doi: 10.1016/j.molmed.2017.01.001. Epub 2017 Feb 7.

    PMID: 28188103BACKGROUND
  • van de Wetering M, Francies HE, Francis JM, Bounova G, Iorio F, Pronk A, van Houdt W, van Gorp J, Taylor-Weiner A, Kester L, McLaren-Douglas A, Blokker J, Jaksani S, Bartfeld S, Volckman R, van Sluis P, Li VS, Seepo S, Sekhar Pedamallu C, Cibulskis K, Carter SL, McKenna A, Lawrence MS, Lichtenstein L, Stewart C, Koster J, Versteeg R, van Oudenaarden A, Saez-Rodriguez J, Vries RG, Getz G, Wessels L, Stratton MR, McDermott U, Meyerson M, Garnett MJ, Clevers H. Prospective derivation of a living organoid biobank of colorectal cancer patients. Cell. 2015 May 7;161(4):933-45. doi: 10.1016/j.cell.2015.03.053.

    PMID: 25957691BACKGROUND
  • Williams JA. Using PDX for Preclinical Cancer Drug Discovery: The Evolving Field. J Clin Med. 2018 Mar 2;7(3):41. doi: 10.3390/jcm7030041.

    PMID: 29498669BACKGROUND
  • Xu H, Lyu X, Yi M, Zhao W, Song Y, Wu K. Organoid technology and applications in cancer research. J Hematol Oncol. 2018 Sep 15;11(1):116. doi: 10.1186/s13045-018-0662-9.

    PMID: 30219074BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Urine sample

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Chi Fai NG, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 13, 2020

Study Start

May 1, 2020

Primary Completion

February 22, 2021

Study Completion

February 22, 2021

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations