CancerNCT04723316
Tumour Characterisation to Guide Experimental Targeted Therapy - National
An observational study of Cancer, run by The Christie NHS Foundation Trust at 20 sites in United Kingdom.
Trial summary
The primary aim of TARGET National is to establish a national framework to offer molecular profiling of circulating tumour DNA and/or tumour tissue (optional) to patients with advanced solid cancers referred to any of the Experimental Cancer Medicine Centres (ECMCs) across the UK, in order to help decision making for… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- How many people
- 6,000 participants
- Where
- 20 sitesUnited Kingdom
- Study dates
- 30 Jun 2021to 30 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Potential study participants will be identified from patients with advanced solid cancer who have been referred for consideration of early phase clinical trials in ECMCs across the UK. Patients who meet the eligibility criteria and provide fully informed written consent will be enrolled into the study
Who may be able to join
- Aged 16 years or over.
- Written informed consent according to GCP and national regulations.
- Patients with confirmed histological or cytological diagnosis of advanced solid cancer who have been referred to any of the ECMCs in the UK AND considered fit enough to receive an experimental therapeutic agent.
- Availability of archival tumour sample (if tumour profiling is required)
- Willingness to provide blood samples during the course of the study if allocated to a matched experimental therapy.
Who cannot join
- Known HIV, Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as HCV RNA detected), due to the difficulties in handling high-risk specimens. Routine testing for hepatitis is not required. Note: Patients with past/resolved Hepatitis B infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients with a history of Hepatitis C infection are eligible only if polymerase chain reaction (PCR) analysis is negative for HCV RNA at least 6 months after completing treatment for Hepatitis C infection.
- Known current COVID19 positive (by PCR) or active symptoms for COVID19. Routine testing for COVID19 is not required. Patients with past infection who have fully recovered may be included.
- Patients who are unable to provide fully informed written consent.
- Patients not considered eligible by the investigator for early phase clinical trials.
- Patients currently receiving systemic anti-cancer therapy (due to potential impact on ctDNA analysis), unless patient has clear evidence of progression on hormone-based therapies or tyrosine kinase inhibitors. A minimum of 3 weeks is required post completion of other systemic anti-cancer therapies.
- Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule.
- Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable fresh tumour biopsies and blood sampling).
- Conditions in which research biopsies or blood sampling may increase risk of complications for the patients and/or investigator
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United Kingdom20 sites, 20 recruiting
- Recruiting
Queen's University Belfast
Belfast, BT7 1NN
Vicky Coyle
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Mark Openshaw
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB20QQ
Bristi Basu
- Recruiting
Cardiff University and Velindre Cancer Centre
Cardiff, CF142TL
Robert Jones
- Recruiting
Western General Hospital Edinburgh Cancer Centre
Edinburgh, EH2 2SP
Stefan Symeonides
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Patricia Roxburgh
- Recruiting
St.James's University Hospital
Leeds, LS97TF
Fiona Collinson
- Recruiting
Leicester Cancer Research Centre
Leicester, LE27LX
Olubukola Ayodele
- Recruiting
Royal Free Hospital
London, NW3 2QG
Robert Goldstein
- Recruiting
Kings Health Partners
London, SE1 9RT
James Spicer
- Not yet recruiting
Imperial College London
London, W120NN
Nicola Valeri
- Recruiting
UCL Cancer Institute
London, WC1E6BT
Martin Forster
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Matthew Krebs, matthew.krebs@nhs.net
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY
Daniel Palmer
- Recruiting
The Newcastle Upon Tyne NHS Foundation Trust
Newcastle, NE7 7DN
Alastair Greystoke
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7DQ
Eileen Parkes
- Recruiting
Royal Preston Hospital
Preston, PR2 9HT
Ruth Board
- Recruiting
Sheffield University Hospitals NHS Foundation Trust
Sheffield, S5 7AU
Robin Young
- Recruiting
University Hospitals Southampton NHS Foundation Trust
Southampton, SO16 6YD
Ellen Copson
- Recruiting
ICR & The Royal Marsden
Sutton, SM2 5NG
Anna Minchom
About this study
The primary aim of TARGET National is to establish a national framework to offer molecular profiling of circulating tumour DNA and/or tumour tissue (optional) to patients with advanced solid cancers referred to any of the Experimental Cancer Medicine Centres (ECMCs) across the UK, in order to help decision making for allocation to molecularly targeted experimental cancer treatments. Patients will be allocated treatment using a national Molecular Tumour Board to find the most suited therapies based on their molecular profiling results.
This study aims to recruit up to 6,000 patients with advanced solid tumours across 5 years and proposes to collect blood samples, archival tumour tissue and fresh tissue (optional)
The data may also be used for future development of predictive cancer biological markers, the design of clinical trials involving new or existing drugs, discovery of new genetic targets and exploring how resistance to specific anticancer agents arises in patients to help improve future cancer treatment management.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the number of patients matched to a trial of an experimental therapeutic agent based on molecular findings from ctDNA or tumour
Measured: 5 years
Secondary outcomes (6)
Number of patients and cancer types with successful result obtained from ctDNA.
Measured: 5 years
Turnaround times from date of patient consent to date of genomic tumour profiling report generation.
Measured: 5 years
Number and range of molecular alterations found in blood (and/or tumour) of cancer patients referred to Experimental Cancer Medicine Centres.
Measured: 5 years
Overall response rates of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched) on the basis of molecular findings in this study).
Measured: 5 years
Progression-free survival of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched on the basis of molecular findings in this study).
Measured: 5 years
Overall survival of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched on the basis of molecular findings in this study).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start30 Jun 2021
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723316
- Sponsor's protocol ID
- CFTSp191
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumour Characterisation to Guide Experimental Targeted Therapy - National
- ClinicalTrials.gov ID
- NCT04723316
- Acronym / sponsor ID
- CFTSp191
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 25 Jan 2021 (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 aim of TARGET National is to establish a national framework to offer molecular profiling of circulating tumour DNA and/or tumour tissue (optional) to patients with advanced solid cancers referred to any of the Experimental Cancer Medicine Centres (ECMCs) across the UK, in order to help decision making for allocation to molecularly targeted experimental cancer treatments. Patients will be allocated treatment using a national Molecular Tumour Board to find the most suited therapies based on their molecular profiling results.
This study aims to recruit up to 6,000 patients with advanced solid tumours across 5 years and proposes to collect blood samples, archival tumour tissue and fresh tissue (optional)
The data may also be used for future development of predictive cancer biological markers, the design of clinical trials involving new or existing drugs, discovery of new genetic targets and exploring how resistance to specific anticancer agents arises in patients to help improve future cancer treatment management.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Potential study participants will be identified from patients with advanced solid cancer who have been referred for consideration of early phase clinical trials in ECMCs across the UK. Patients who meet the eligibility criteria and provide fully informed written consent will be enrolled into the study
Key inclusion criteria (5 listed)
- Aged 16 years or over.
- Written informed consent according to GCP and national regulations.
- Patients with confirmed histological or cytological diagnosis of advanced solid cancer who have been referred to any of the ECMCs in the UK AND considered fit enough to receive an experimental therapeutic agent.
- Availability of archival tumour sample (if tumour profiling is required)
- Willingness to provide blood samples during the course of the study if allocated to a matched experimental therapy.
Key exclusion criteria (8 listed)
- Known HIV, Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as HCV RNA detected), due to the difficulties in handling high-risk specimens. Routine testing for hepatitis is not required. Note: Patients with past/resolved Hepatitis B infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients with a history of Hepatitis C infection are eligible only if polymerase chain reaction (PCR) analysis is negative for HCV RNA at least 6 months after completing treatment for Hepatitis C infection.
- Known current COVID19 positive (by PCR) or active symptoms for COVID19. Routine testing for COVID19 is not required. Patients with past infection who have fully recovered may be included.
- Patients who are unable to provide fully informed written consent.
- Patients not considered eligible by the investigator for early phase clinical trials.
- Patients currently receiving systemic anti-cancer therapy (due to potential impact on ctDNA analysis), unless patient has clear evidence of progression on hormone-based therapies or tyrosine kinase inhibitors. A minimum of 3 weeks is required post completion of other systemic anti-cancer therapies.
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
To determine the number of patients matched to a trial of an experimental therapeutic agent based on molecular findings from ctDNA or tumour
Time frame: 5 years
6 secondary outcomes
Number of patients and cancer types with successful result obtained from ctDNA.
Time frame: 5 years
Turnaround times from date of patient consent to date of genomic tumour profiling report generation.
Time frame: 5 years
Number and range of molecular alterations found in blood (and/or tumour) of cancer patients referred to Experimental Cancer Medicine Centres.
Time frame: 5 years
Overall response rates of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched) on the basis of molecular findings in this study).
Time frame: 5 years
Progression-free survival of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched on the basis of molecular findings in this study).
Time frame: 5 years
Overall survival of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched on the basis of molecular findings in this study).
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The Christie NHS Foundation Trust at 20 sites in United Kingdom.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Krebs (01619187672, the-christie.target.national@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the number of patients matched to a trial of an experimental therapeutic agent based on molecular findings from ctDNA or tumour (time frame: 5 years). 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 7 Feb 2024.