Tumour Characterisation to Guide Experimental Targeted Therapy - National

Sponsor
The Christie NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04723316
Collaborator
(none)
6,000
Enrollment
9
Locations
79
Anticipated Duration (Months)
666.7
Patients Per Site
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Tumour Characterisation to Guide Experimental Targeted Therapy - National
    Actual Study Start Date :
    Jun 30, 2021
    Anticipated Primary Completion Date :
    Jan 30, 2026
    Anticipated Study Completion Date :
    Jan 30, 2028

    Outcome Measures

    Primary Outcome Measures

    1. To determine the number of patients matched to a trial of an experimental therapeutic agent based on molecular findings from ctDNA or tumour [5 years]

    Secondary Outcome Measures

    1. Number of patients and cancer types with successful result obtained from ctDNA. [5 years]

    2. Turnaround times from date of patient consent to date of genomic tumour profiling report generation. [5 years]

    3. Number and range of molecular alterations found in blood (and/or tumour) of cancer patients referred to Experimental Cancer Medicine Centres. [5 years]

    4. 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). [5 years]

    5. 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). [5 years]

    6. 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). [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Queen's University BelfastBelfastUnited KingdomBT7 1NN
    2Cambridge University Hospitals NHS Foundation TrustCambridgeUnited KingdomCB20QQ
    3Western General Hospital Edinburgh Cancer CentreEdinburghUnited KingdomEH2 2SP
    4Beatson West of Scotland Cancer CentreGlasgowUnited KingdomG12 0YN
    5St.James's University HospitalLeedsUnited KingdomLS97TF
    6The Christie NHS Foundation TrustManchesterUnited KingdomM20 4BX
    7The Newcastle Upon Tyne NHS Foundation TrustNewcastleUnited KingdomNE7 7DN
    8Sheffield University Hospitals NHS Foundation TrustSheffieldUnited KingdomS5 7AU
    9The Clatterbridge Cancer Centre NHS Foundation TrustWirralUnited KingdomCH63 4JY

    Sponsors and Collaborators

    • The Christie NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Christie NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT04723316
    Other Study ID Numbers:
    • CFTSp191
    First Posted:
    Jan 25, 2021
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 7, 2021