Tumour Characterisation to Guide Experimental Targeted Therapy - National

February 6, 2024 updated by: The Christie NHS Foundation Trust

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT7 1NN
        • Recruiting
        • Queen's University Belfast
        • Contact:
          • Vicky Coyle
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
          • Mark Openshaw
      • Cambridge, United Kingdom, CB20QQ
        • Recruiting
        • Cambridge University Hospitals Nhs Foundation Trust
        • Contact:
          • Bristi Basu
      • Cardiff, United Kingdom, CF142TL
        • Recruiting
        • Cardiff University and Velindre Cancer Centre
        • Contact:
          • Robert Jones
      • Edinburgh, United Kingdom, EH2 2SP
        • Recruiting
        • Western General Hospital Edinburgh Cancer Centre
        • Contact:
          • Stefan Symeonides
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre
        • Contact:
          • Patricia Roxburgh
      • Leeds, United Kingdom, LS97TF
        • Recruiting
        • St.James's University Hospital
        • Contact:
          • Fiona Collinson
      • Leicester, United Kingdom, LE27LX
        • Recruiting
        • Leicester Cancer Research Centre
        • Contact:
          • Olubukola Ayodele
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
          • Robert Goldstein
      • London, United Kingdom, W120NN
        • Not yet recruiting
        • Imperial College London
        • Contact:
          • Nicola Valeri
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Kings Health Partners
        • Contact:
          • James Spicer
      • London, United Kingdom, WC1E6BT
        • Recruiting
        • UCL Cancer Institute
        • Contact:
          • Martin Forster
      • London Borough of Sutton, United Kingdom, SM2 5NG
        • Recruiting
        • ICR & The Royal Marsden
        • Contact:
          • Anna Minchom
      • Manchester, United Kingdom, M20 4BX
      • Newcastle, United Kingdom, NE7 7DN
        • Recruiting
        • The Newcastle upon Tyne NHS Foundation Trust
        • Contact:
          • Alastair Greystoke
      • Oxford, United Kingdom, OX3 7DQ
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Contact:
          • Eileen Parkes
      • Preston, United Kingdom, PR2 9HT
        • Recruiting
        • Royal Preston Hospital
        • Contact:
          • Ruth Board
      • Sheffield, United Kingdom, S5 7AU
        • Recruiting
        • Sheffield University Hospitals NHS Foundation Trust
        • Contact:
          • Robin Young
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospitals Southampton NHS Foundation Trust
        • Contact:
          • Ellen Copson
      • Wirral, United Kingdom, CH63 4JY
        • Recruiting
        • The Clatterbridge Cancer Centre NHS Foundation Trust
        • Contact:
          • Daniel Palmer

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  1. Aged 16 years or over.
  2. Written informed consent according to GCP and national regulations.
  3. 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.
  4. Availability of archival tumour sample (if tumour profiling is required)
  5. Willingness to provide blood samples during the course of the study if allocated to a matched experimental therapy.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Patients who are unable to provide fully informed written consent.
  4. Patients not considered eligible by the investigator for early phase clinical trials.
  5. 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.
  6. 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.
  7. 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).
  8. Conditions in which research biopsies or blood sampling may increase risk of complications for the patients and/or investigator

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of patients and cancer types with successful result obtained from ctDNA.
Time Frame: 5 years
5 years
Turnaround times from date of patient consent to date of genomic tumour profiling report generation.
Time Frame: 5 years
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
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
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
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
5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Christie NHS Foundation Trust

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CFTSp191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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