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Tumour Characterisation to Guide Experimental Targeted Therapy - National

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ClinicalTrials.gov Identifier: NCT04723316
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
The Christie NHS Foundation Trust

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 disease
Cancer

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



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 [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of patients and cancer types with successful result obtained from ctDNA. [ Time Frame: 5 years ]
  2. Turnaround times from date of patient consent to date of genomic tumour profiling report generation. [ Time Frame: 5 years ]
  3. 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 ]
  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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA

Blood samples will be collected for ctDNA analysis and germline DNA analysis Tissue samples will be collected for next generation sequencing. Whilst the focus of the study is on next generation sequencing of circulating tumour DNA, the study is not restricted to these analyses. Other tests may be performed, including, but not restricted to: immunohistochemistry, FISH, PCR if such analyses complement the panel of aberrations that may help select a relevant trial of an experimental therapeutic for participating patients.

Fresh tumour may also be used for in vitro (i.e. organoids) and/or in vivo experiments (mouse models) (optional) if patients provide their consent. These crucial experiments will improve our understanding of the biology of cancer and will lead to identification of new potential targets for cancer patients, facilitate drug screening and will inform of mechanisms of drug resistance.

In summary, analyses may be varied and alter over time as technologies evolve.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723316


Contacts
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Contact: Matthew Krebs 01619187672 matthew.krebs@nhs.net

Locations
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United Kingdom
Queen's University Belfast Recruiting
Belfast, United Kingdom, BT7 1NN
Contact: Vicky Coyle         
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom, CB20QQ
Contact: Bristi Basu         
Western General Hospital Edinburgh Cancer Centre Not yet recruiting
Edinburgh, United Kingdom, EH2 2SP
Contact: Stefan Symeonides         
Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Patricia Roxburgh         
St.James's University Hospital Recruiting
Leeds, United Kingdom, LS97TF
Contact: Fiona Collinson         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Matthew Krebs       matthew.krebs@nhs.net   
The Newcastle Upon Tyne NHS Foundation Trust Recruiting
Newcastle, United Kingdom, NE7 7DN
Contact: Alastair Greystoke         
Sheffield University Hospitals NHS Foundation Trust Not yet recruiting
Sheffield, United Kingdom, S5 7AU
Contact: Robin Young         
The Clatterbridge Cancer Centre NHS Foundation Trust Recruiting
Wirral, United Kingdom, CH63 4JY
Contact: Daniel Palmer         
Sponsors and Collaborators
The Christie NHS Foundation Trust
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Responsible Party: The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04723316    
Other Study ID Numbers: CFTSp191
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No