Cancer Clinical Trial
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.
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.
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.
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