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

October 21, 2020 updated by: Imperial College London

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

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.

Study Overview

Status

Not yet recruiting

Detailed Description

This is a A Phase II multi-centre prediction study of the Curesponse Ex Vivo Organ Culture (EVOC) model in patients with suspected or confirmed advanced or metastatic malignancy.

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 will be recruited for this study.

Patients will undergo a research biopsy where up to 6 tissue samples will be collected. Patients will also have the option to provide an additional single blood sample for germline genetic testing. Patients will then attend their hospital clinical to receive standard of care anticancer therapy as discussed with their oncologist.

Concurrently to the patients treatment, the tissue samples will be transported to the Curesponse laboratory for the development of the EVOC. The EVOC will be treated with a range of anticancer therapies, including the same treatment that the patient will be receiving in clinic. The model will predict whether the cancer will respond to the therapy. Additionally, providing the patient consents, the tissue will also undergo tumour gene profiling related to the secondary and exploratory endpoints and objectives.

Study Type

Observational

Enrollment (Anticipated)

248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The EVOC to demonstrate a sensitivity and specificity of at least 70% for predicting a patients clinical response to a specific anti-cancer therapy
Time Frame: From biopsy to the end of the patient's final imaging response assessment at Follow up 3.
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
Time Frame: During the biopsy
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.
Time Frame: From pre-treatment of EVOC up to the end of treatment on the EVOC model.
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.
Time Frame: End of treatment on EVOC model.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the clinical utility of the EVOC compared to other predictions of response via additional technologies for cancer treatment.
Time Frame: Biopsy up to end of treatment of EVOC.
Assessed by genomic profiling where relevant, and the comparison of tumour gene profiling to germline genetic testing.
Biopsy up to end of treatment of EVOC.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jonathan Krell, Dr, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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