Acceptability and Feasibility Study of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools

NCT03300102 | Completed

• 1 other identifier: 17/0351
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cancer

Keywords

personalised medicine

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Measured using a Likert scale non-validated structured questionnaire and/or complete a semi structured interview.

  Up to 10 weeks after consent

Secondary Outcomes (7)

• Feasibility : Number of tumour tissue samples collected

  Up to 10 weeks after consent

• Feasibility : Gross morphology, weight and size of each sample

  Up to 10 weeks after consent

• Feasibility : Cell count after isolation

  Up to 10 weeks after consent

• Feasibility: Cell growth method and time

  10 days after tumouroid establishment

• Feasibility: Drug concentrations tested

  On day 10 after tumouroid establishment

Study Arms (1)

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.

Other: Questionnaires, interviews and or tissue donation

Interventions

Questionnaires, interviews and or tissue donation OTHER

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.

Patients with suspected or confirmed renal cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adult patients (≥18 years old), of either gender, able to provide consent;
• Suspected or confirmed renal cell carcinoma;
• Signed informed consent by patient

You may not qualify if:

• Non-English speaker;
• Inability to provide informed consent

Sponsors & Collaborators

• University College, London: lead

Study Sites (2)

Surgical & Interventional Trials Unit

London, NW12BX, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31851732 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires; Interviews as Topic; Tissue and Organ Procurement

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mark Emberton

  Professor of Interventional Oncology, UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: October 3, 2017
• Study Start: January 10, 2018
• Primary Completion: August 1, 2018
• Study Completion: December 31, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

GB (2)