Advanced CancerCURESPONSENCT04599608
Prediction of Drug Response Using an Ex Vivo Organ Culture (EVOC) on Fresh Human Tumour Samples From Metastatic Patients
An observational study of Advanced Cancer and Metastatic Cancer, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Cancer, Metastatic Cancer
- Keywords
- Ex Vivo Organ Culture, Biopsy, Advanced/Metastatic cancer, Prediction of response to cancer treatment
- Medical subject headings
- Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Assessed by genomic profiling where relevant, and the comparison of tumour gene profiling to germline genetic testing.
Measured: Biopsy up to end of treatment of EVOC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startFeb 2021 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Curesponse Ltd.
- Responsible party
- Sponsor
- Investigators
- Jonathan Krell, Dr, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599608
- Sponsor's protocol ID
- 20HH6332
- Acronym
- CURESPONSE
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Patient Drug Response Using an Ex Vivo Organ Culture (EVOC) on Fresh Human Tumour Samples From Metastatic Patients
- ClinicalTrials.gov ID
- NCT04599608
- Acronym / sponsor ID
- CURESPONSE / 20HH6332
- Conditions
- Advanced Cancer, Metastatic Cancer
- Keywords
- Ex Vivo Organ Culture, Biopsy, Advanced/Metastatic cancer, Prediction of response to cancer treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Curesponse Ltd.
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Krell, Dr principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Metastatic Cancer, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayushi J Pabari (+44 (0)20 3313 0684, a.pabari@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.