Prediction of Drug Response Using an Ex Vivo Organ Culture (EVOC) on Fresh Human Tumour Samples From Metastatic Patients

NCT04599608 | Unknown DMC

• 1 other identifier: 20HH6332
• Study Type: observational
• Target: 248
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to determine how sensitive and specific the Curesponse Ex Vivo Organ Culture (EVOC) model is at predicting a patient's clinical response to a specific cancer therapy. 248 patients from participating UK hospitals will have a biopsy for the development of an Ex-vivo organ culture at the Curesponse Laboratory. Patients will have standard of care anticancer therapy after the biopsy and be followed up for 6 months following their biopsy. The combined results of the study will show whether the EVOC has potential to be useful for future patients prospectively in determining whether a certain clinical treatment is likely to benefit them.

Conditions

Advanced Cancer; Metastatic Cancer

Keywords

Ex Vivo Organ Culture; Biopsy; Advanced/Metastatic cancer; Prediction of response to cancer treatment

Outcome Measures

Primary Outcomes (4)

• The EVOC to demonstrate a sensitivity and specificity of at least 70% for predicting a patients clinical response to a specific anti-cancer therapy

  Comparison of patient's treatment clinical to the EVOC treated with the same therapy.

  From biopsy to the end of the patient's final imaging response assessment at Follow up 3.

• Assessment of tumour heterogeneity in relation to treatment response using the EVOC model

  Tumour gene profiling on tissue samples obtained at the biopsy

  During the biopsy

• Assess variability in cell populations within the EVOC before and after treatment.

  FACS and other methods of analysis to analyse the changes in cell population of the EVOC.

  From pre-treatment of EVOC up to the end of treatment on the EVOC model.

• Evaluation and characterisation of viable and resistant cancer cells in the EVOC following treatment and assessment of their response to other therapeutic agents.

  Following treatment of EVOC, viable/resistant cancer cells to be extracted and harvested, to be further grown for further treatment response assessments in the laboratory.

  End of treatment on EVOC model.

Secondary Outcomes (1)

• Comparison of the clinical utility of the EVOC compared to other predictions of response via additional technologies for cancer treatment.

  Biopsy up to end of treatment of EVOC.

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

Patients with suspected or confirmed, advanced or metastatic malignancy in whom at least 1 site is amenable for biopsy, and who would be planned to receive systemic anti-cancer therapy, where disease response can be measured by conventional imaging methods.

You may qualify if:

• Suspected or confirmed advanced or metastatic cancer
• Aged \> 18 years
• Life expectancy \> 3 months
• ECOG Performance Status 0-2
• At least one tumour lesion which is amenable for 16 G biopsy (minimum of 2 cores)
• Planned to receive standard of care therapy or an experimental treatment as part of a clinical trial following the biopsy
• Written informed consent and ability to comply with study protocol
• Measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 by CT or MRI

You may not qualify if:

• Pregnant and/or breastfeeding woman
• Lesion is non accessible
• Any other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study
• Known carrier for acquired immune deficiency syndrome (AIDS)
• Known carrier for hepatitis B or hepatitis C virus indicating acute or chronic infection

Sponsors & Collaborators

• Imperial College London: lead
• Curesponse Ltd.: collaborator

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Krell, Dr

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayushi J Pabari

CONTACT

+44 (0)20 3313 0684; a.pabari@imperial.ac.uk

Study Design

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

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: January 1, 2026
• Last Updated: October 22, 2020

Record last verified: 2020-10