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Kidney CancerNCT04342286

To Establish a Reproducible Organoid Culture Model With Human Kidney Cancer

An observational study of Kidney Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
Organoid culture
How many people
20 participants
Where
1 siteHong Kong
Study dates
1 May 2020to 22 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

About this study

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.

Read the detailed description

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. The rapid increase in incidence is partly due to the greater prevalence of putative risk factors including smoking, obesity, and hypertension, as well as improvements in diagnostic imaging. 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. Fortunately, with recent advances in the development of novel therapeutic agents, there are many potential effective treatments available for patients, including tyrosine kinase inhibitors, mammalian target of rapamycin (mTOR) inhibitors, immune checkpoint blockers etc. Facing the wide range of available options for systemic therapy, the current challenge is how to select the most effective treatment for individual patients, in particular as the first line therapy.

Currently, there are some guidelines, basing on the clinical parameters and tumor subtype and grading, for selection of therapy for patients.Unfortunately, there is no good biomarkers available to aid treatment selection. As there is increasing recognition of inter-tumor variation, therefore, there is a need to develop more personalized approach to assess the treatment response of individual patient / cancer to the panel of available drugs, in order to select the best options for each patient.

Three-dimensional (3D) organoid culture model and its potential advantages Organoid technology has recently emerged to become an independent research tool and can provide opportunities for new drug development and drug screening. Organoids are cell-derived in vitro 3D organ constructs which allow the study of many biological processes. This specific model can be developed from embryonic stem cells (ESCs), induced pluripotent stem cells (iPSCs), somatic SCs, and cancer cells in specific 3D culture systems. These groundbreaking 3D tissues were first created in the laboratory in small scale and closely resembled the parent organ in vivo in terms of its structure and function. The major benefits of the 3D organoid culture model include, firstly, it contains multiple cell types comparable with the in vivo counterpart; secondly, the cells inside the 3D structure can organize similarly to the primary tissue; and lastly, it functions specifically like the parent organ. With the scaffold supporting and the nascent phenotype needed, emerging 3D culture methods can improve our ability to model tumor behavior in vitro and provide a native environment for different research purposes, such as cell behavior, tissue repair, drugs screening and mutation monitoring. Development of kidney cancer organoid Different studies have demonstrated that gastrointestinal cancers organoid models provide better prediction to a patient's treatment responses. There is limited publication on successful 3D kidney cancer organoid recently, and the one published by Batchelder CA in 2015 had analyzed limited amount of genes. Besides, majority of the cases reported had been undergone 2D culture on plasticwares before implanting inside the 3D scaffold, which may offer the chance of cells selection.Lacking a widely acceptable 3D kidney cancer model, this pushes the need to develop a reproducible kidney cancer organoid system for better drug selection on significant heterogeneity cancers. In our study, total cells will be mixed with the Matrigel scaffold without any manipulation or culture selection, and more advance Next Generation Sequencing will be used to evaluate the genetic similarity of the culture organoids and the primary tissues. Starting as a major technological breakthrough, 3D organoids are now more firmly established as an essential tool in biological research and have important implications for clinical use. In the future, successful expansion of the model can provide a platform to identify the most effective personalized treatment option and improve the treatment outcome of kidney cancer patients.

Therefore, investigator proposed to establish a sustainable human kidney tumor 3D Matrigel culture system with a stable phenotype from local population. Investigators hypothesize that the successful of our project would produce reliable and effective method to cultivate kidney cancer cells from our local patients, and will provide personalized and targeted therapy on kidney cancer for local Hong Kong patients.

Conditions
Kidney Cancer
Being tested
Organoid culture
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Organoid cultureGenetic

    Organoid culture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (2)
  1. The identicality of histopathological detail and genomic information of the kidney cancer organoid compared with the original primary tissue

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

    Measured: 2 years

  2. The tumorigenicity ability of the kidney cancer organoid in nude mice

    The tumorigenicity ability will be assessed by nude mice injection

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start1 May 2020
  3. Primary completion22 Feb 2021
  4. Study completion22 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04342286
Sponsor's protocol ID
CRE-2019.211
Status last verified
Oct 2026
First submitted
8 Apr 2020
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31142512
  • 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.

    PubMed 26317980
  • 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.

    PubMed 3335022
  • 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.

    PubMed 26797458
  • 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.

    PubMed 26479923
  • 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.

    PubMed 25533785
  • 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.

    PubMed 30726695
  • 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.

    PubMed 28098136
  • 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.

    PubMed 30372392
  • 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.

    PubMed 28670477
  • 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.

    PubMed 28188103
  • 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.

    PubMed 25957691
  • 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.

    PubMed 29498669
  • 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.

    PubMed 30219074

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish a sustainable human kidney tumor 3D Matrigel culture system with a stable phenotype (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342286, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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