Cancer Clinical Trial
— TumouroidsOfficial title:
A Single Site Study Accessing the Acceptability and Feasibility of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools
NCT number | NCT03300102 |
Other study ID # | 17/0351 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 10, 2018 |
Est. completion date | December 31, 2018 |
Verified date | January 2019 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | December 31, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients (=18 years old), of either gender, able to provide consent; - Suspected or confirmed renal cell carcinoma; - Signed informed consent by patient Exclusion Criteria: - Non-English speaker; - Inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Free Hospital | London | |
United Kingdom | Surgical & Interventional Trials Unit | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability | Measured using a Likert scale non-validated structured questionnaire and/or complete a semi structured interview. | Up to 10 weeks after consent | |
Secondary | 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. | Up to 10 weeks after consent | |
Secondary | Feasibility : Gross morphology, weight and size of each sample | Each sample obtained will be weighed and measured. | Up to 10 weeks after consent | |
Secondary | Feasibility : Cell count after isolation | A physical count of the number of cells isolated from each sample will be collected. | Up to 10 weeks after consent | |
Secondary | 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.. | 10 days after tumouroid establishment | |
Secondary | Feasibility: Drug concentrations tested | A log will be kept of the drug concentrations used on all tumouroids. | On day 10 after tumouroid establishment | |
Secondary | Feasibility: Duration of drug exposure | Number of days tumouroid was exposed to drug | 5 days of drug exposure | |
Secondary | 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. | within 6 days of the end of drug exposure. |
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