CancerTumouroidsNCT03300102
Acceptability and Feasibility Study of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools
An observational study of Cancer, run by University College, London at 2 sites in United Kingdom.
Trial summary
In England, more than three hundred thousand people are diagnosed with cancer each year. The diagnostic and treatment pathways for multiple cancers have greatly developed over the past decade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaires, interviews and or tissue donation
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Jan 2018to 31 Dec 2018
- 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: Male or female patients aged 18 or over, sufficient command of English language to complete consent forms and questionnaires, suspected or confirmed renal cell carcinoma.
Who may be able to join
- Adult patients (≥18 years old), of either gender, able to provide consent;
- Suspected or confirmed renal cell carcinoma;
- Signed informed consent by patient
Who cannot join
- Non-English speaker;
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Surgical & Interventional Trials Unit
London, NW12BX
Royal Free Hospital
London, NW3 2QG
About this study
Official title: A Single Site Study Accessing the Acceptability and Feasibility of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools
In England, more than three hundred thousand people are diagnosed with cancer each year. The diagnostic and treatment pathways for multiple cancers have greatly developed over the past decade. However, novel treatments are expensive and currently discrimination between responders and non-responders is still suboptimal. There is a pressing need to develop tools that allow for better disease characterisation and stratification. Personalised medicine, whereby prevention, diagnosis, and treatment of diseases is aimed at the individual level, is a growing field. Predicting patient-specific treatment response is challenging as response depends not only on the characteristics of cancer cells but also on how these cells interact with their immediate surrounding environment and on how the tumour interacts with the host. A simplistic model is therefore insufficient to predict treatment response. Complex, patient-derived animal models have been used to this effect but are expensive, may take up to 6 months to provide clinically relevant answers, and pose ethical issues. In the past in vitro models lacked complexity as they were based solely on the two-dimensional (2D) growth of cancer cells. Nowadays the use of 3D tumour models has provided an extra level of complexity to in vitro studies. With these models it is possible to recreate tumour characteristics that were lost in 2D, such as cell-cell interaction between cancer cells and between cancer and stromal cells, cell-matrix interaction, or hypoxia.
The investigators have developed a 3D complex tumour model - named tumouroid. Using this model, preliminary work has been undertaken which allows the growth of patient-derived tumouroids using primary cancer cells from patients.
Read more
This personalised platform can be challenged by therapeutics used in clinical practice and response to treatment can be assessed via appropriate assays.
The study goals are twofold:
To assess patient acceptability to the use of patient derived tumour models for future decision-making, and To assess the feasibility of generating patient derived renal cancer tumouroids and using them as platforms to test drug response.
Read the detailed description
This trial is a prospective tissue collection of renal cell carcinoma samples, including collection of data using both structured Likert 12 item questionnaires and semi structured interviews to assess acceptability. With the development of patient-derived tumouroids the investigators would like to overcome the current over-simplified strategies that focus on genetic markers as predictors of response. In the future, the investigators hope to establish tumouroids as a personalised platform to predict patient response to treatment that is more cost-efficient and poses less ethical issues than animal platforms.
This project will assess if patient-derived tumouroids can be therapeutically challenged and if patients would be willing to accept that such platform to guide clinical treatment decision making.
This study is designed to assess primarily patient acceptability. Acceptability will be elicited using Likert scale non-validated questionnaires and in a semi-structured interview in which the views and preferences relating the acceptability or otherwise of the patient derived tumour models and their impact on future decision making will be explored.
The study will also assess feasibility of building tumouroids and challenging them. Feasibility will address the successful transition between the critical phases of generating a viable and responsive tumour model. This begins with the extraction of cancer cells from the explanted tumour and ends with the determination of a response or otherwise to a therapeutic challenge of the viable tumour model at a range of in vitro concentrations.
The findings of this study will be presented at conference(s) and manuscripts will be submitted to appropriate journals for publication.
- Conditions
- Cancer
- Being tested
- Questionnaires, interviews and or tissue donation
- Keywords
- personalised medicine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, interviews and or tissue donationOther
Subjects will be asked to complete either structured questionnaires, semi-structured interviews or donate tissue. There will be some overlap, but each subject does not have to do all three interventions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected or confirmed renal cell carcinoma | Patients with suspected or confirmed renal cell carcinoma who have consented will either donate tissue, or complete a structured questionnaire or a semi-structured interview. Not all patients will have all three interventions, each patient must have at least one. Receives: Other: Questionnaires, interviews and or tissue donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Measured using a Likert scale non-validated structured questionnaire and/or complete a semi structured interview.
Measured: Up to 10 weeks after consent
Secondary outcomes (7)
Feasibility : Number of tumour tissue samples collected
Number of tumour tissue samples that can be collected within the time frame from consented patients this will be counted.
Measured: Up to 10 weeks after consent
Feasibility : Gross morphology, weight and size of each sample
Each sample obtained will be weighed and measured.
Measured: Up to 10 weeks after consent
Feasibility : Cell count after isolation
A physical count of the number of cells isolated from each sample will be collected.
Measured: Up to 10 weeks after consent
Feasibility: Cell growth method and time
Measurements will be taken of each tumouroid as it grows, each tumouroid will be given ten days to grow at day ten drug challenge will begin..
Measured: 10 days after tumouroid establishment
Feasibility: Drug concentrations tested
A log will be kept of the drug concentrations used on all tumouroids.
Measured: On day 10 after tumouroid establishment
Feasibility: Duration of drug exposure
Number of days tumouroid was exposed to drug
Measured: 5 days of drug exposure
Feasibility: Drug challenge response
At the end of 5 days of drug exposure tumouroids will be assessed for response to the drug using a commercially available kit that assesses cell metabolism and viability. In addition, tumouroids will be fixed so that cell morphology will be assessed within 6 days of the end of drug exposure.
Measured: within 6 days of the end of drug exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start10 Jan 2018
- Primary completion1 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Emberton, Principal investigator, Professor of Interventional Oncology, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300102
- Sponsor's protocol ID
- 17/0351
- Acronym
- Tumouroids
- Status last verified
- Jan 2019
- First submitted
- 12 Jul 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tran MGB, Neves JB, Stamati K, Redondo P, Cope A, Brew-Graves C, Williams NR, Grierson J, Cheema U, Loizidou M, Emberton M. Acceptability and feasibility study of patient-specific 'tumouroids' as personalised treatment screening tools: Protocol for prospective tissue and data collection of participants with confirmed or suspected renal cell carcinoma. Int J Surg Protoc. 2019 Apr 2;14:24-29. doi: 10.1016/j.isjp.2019.03.019. eCollection 2019.
PubMed 31851732
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site Study Accessing the Acceptability and Feasibility of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools
- ClinicalTrials.gov ID
- NCT03300102
- Acronym / sponsor ID
- Tumouroids / 17/0351
- Conditions
- Cancer
- Keywords
- personalised medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In England, more than three hundred thousand people are diagnosed with cancer each year. The diagnostic and treatment pathways for multiple cancers have greatly developed over the past decade. However, novel treatments are expensive and currently discrimination between responders and non-responders is still suboptimal. There is a pressing need to develop tools that allow for better disease characterisation and stratification. Personalised medicine, whereby prevention, diagnosis, and treatment of diseases is aimed at the individual level, is a growing field. Predicting patient-specific treatment response is challenging as response depends not only on the characteristics of cancer cells but also on how these cells interact with their immediate surrounding environment and on how the tumour interacts with the host. A simplistic model is therefore insufficient to predict treatment response. Complex, patient-derived animal models have been used to this effect but are expensive, may take up to 6 months to provide clinically relevant answers, and pose ethical issues. In the past in vitro models lacked complexity as they were based solely on the two-dimensional (2D) growth of cancer cells. Nowadays the use of 3D tumour models has provided an extra level of complexity to in vitro studies. With these models it is possible to recreate tumour characteristics that were lost in 2D, such as cell-cell interaction between cancer cells and between cancer and stromal cells, cell-matrix interaction, or hypoxia.
The investigators have developed a 3D complex tumour model - named tumouroid. Using this model, preliminary work has been undertaken which allows the growth of patient-derived tumouroids using primary cancer cells from patients.
This personalised platform can be challenged by therapeutics used in clinical practice and response to treatment can be assessed via appropriate assays.
The study goals are twofold:
To assess patient acceptability to the use of patient derived tumour models for future decision-making, and To assess the feasibility of generating patient derived renal cancer tumouroids and using them as platforms to test drug response.
Detailed description
This trial is a prospective tissue collection of renal cell carcinoma samples, including collection of data using both structured Likert 12 item questionnaires and semi structured interviews to assess acceptability. With the development of patient-derived tumouroids the investigators would like to overcome the current over-simplified strategies that focus on genetic markers as predictors of response. In the future, the investigators hope to establish tumouroids as a personalised platform to predict patient response to treatment that is more cost-efficient and poses less ethical issues than animal platforms.
This project will assess if patient-derived tumouroids can be therapeutically challenged and if patients would be willing to accept that such platform to guide clinical treatment decision making.
This study is designed to assess primarily patient acceptability. Acceptability will be elicited using Likert scale non-validated questionnaires and in a semi-structured interview in which the views and preferences relating the acceptability or otherwise of the patient derived tumour models and their impact on future decision making will be explored.
The study will also assess feasibility of building tumouroids and challenging them. Feasibility will address the successful transition between the critical phases of generating a viable and responsive tumour model. This begins with the extraction of cancer cells from the explanted tumour and ends with the determination of a response or otherwise to a therapeutic challenge of the viable tumour model at a range of in vitro concentrations.
The findings of this study will be presented at conference(s) and manuscripts will be submitted to appropriate journals for publication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected or confirmed renal cell carcinoma | – | Other: Questionnaires, interviews and or tissue donationPatients with suspected or confirmed renal cell carcinoma who have consented will either donate tissue, or complete a structured questionnaire or a semi-structured interview. Not all patients will have all three interventions, each patient must have at least one. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients aged 18 or over, sufficient command of English language to complete consent forms and questionnaires, suspected or confirmed renal cell carcinoma.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old), of either gender, able to provide consent;
- Suspected or confirmed renal cell carcinoma;
- Signed informed consent by patient
Key exclusion criteria (2 listed)
- Non-English speaker;
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires, interviews and or tissue donationSubjects will be asked to complete either structured questionnaires, semi-structured interviews or donate tissue. There will be some overlap, but each subject does not have to do all three interventions. | Other | Patients with suspected or confirmed renal cell carcinoma |
Primary outcome
Acceptability
Time frame: Up to 10 weeks after consent
Measured using a Likert scale non-validated structured questionnaire and/or complete a semi structured interview.
7 secondary outcomes
Feasibility : Number of tumour tissue samples collected
Time frame: Up to 10 weeks after consent
Feasibility : Gross morphology, weight and size of each sample
Time frame: Up to 10 weeks after consent
Feasibility : Cell count after isolation
Time frame: Up to 10 weeks after consent
Feasibility: Cell growth method and time
Time frame: 10 days after tumouroid establishment
Feasibility: Drug concentrations tested
Time frame: On day 10 after tumouroid establishment
Feasibility: Duration of drug exposure
Time frame: 5 days of drug exposure
Feasibility: Drug challenge response
Time frame: within 6 days of the end of drug exposure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 31851732Tran MGB, Neves JB, Stamati K, Redondo P, Cope A, Brew-Graves C, Williams NR, Grierson J, Cheema U, Loizidou M, Emberton M. Acceptability and feasibility study of patient-specific 'tumouroids' as personalised treatment screening tools: Protocol for prospective tissue and data collection of participants with confirmed or suspected renal cell carcinoma. Int J Surg Protoc. 2019 Apr 2;14:24-29. doi: 10.1016/j.isjp.2019.03.019. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Emberton principal investigator
Professor of Interventional Oncology, UCL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University College, London at 2 sites in United Kingdom.
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 3 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 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Acceptability (time frame: Up to 10 weeks after consent). 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 NCT03300102, which also lists 1 linked publication.
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 24 Jan 2019.