Testing tumour genetics in patients with cancers resistant to standard-of-care therapy

IMAGINE: Integrating Medically Actionable Genomics INto Early-phase trials

Registry ID
ISRCTN42303887
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Greater Glasgow & Clyde NHS Board
Enrollment
200
Start date
2020-01-07
Completion date
2026-09-30
Last update
2026-08-17

Conditions

Summary

Cancer patients who are referred for an early-phase clinical trial.

Detailed description

Patients that are referred to the early-phase trials clinic at the Beatson West of Scotland Cancer Centre and are assessed as being potential early-phase clinical trial participants will be given a patient information sheet regarding this study and will be given the opportunity to consent to study participation. After written informed consent has been obtained, image-guided/other suitable biopsies will be performed according to local standard management where possible. Since patients referred for an early phase clinical trial are not restricted to defined tumour sites, biopsies may be obtained from a variety of anatomical locations. Archival tissue will be obtained where a biopsy is not feasible or when the biopsy tissue failed to lead to generation of a molecular profile. Blood samples will also be taken for isolation of DNA and to examine circulating tumour markers. Inclusion Criteria 3b eIMAGINE is the database that has been developed to capture the molecular and clinical data generated in the IMAGINE study. Patients who are referred to the early-phase trials clinic who have already had tumour sequencing performed (and are not fit/willing to have a research biopsy) will instead be able to contribute their clinical and sequencing data to eIMAGINE via inclusion certiate 3b. Although these patients will not contribute to the primary or secondary objectives their clinical and sequencing data will make a valuable contribution to translational research studies examining associations between molecular aberrations and response and resistance. Patients who enter the study under inclusion criteria 3b will not be asked to provide tumour or blood samples. Patient's who have consented to blood and tissue collection will remain on study until the last blood sample is collected at progressive disease. The median time for this is approximately 5 months. With the exception of patients attending for additional biopsy, visits will be conducted as per standard of care for th

Interventions

Inclusion criteria

1. Adult patients aged 18 years or over 2. Patients referred for an early-phase clinical trial with histologically confirmed advanced solid tumours 3. Patient meets one of the following criteria: 3.1. Willing and fit to have a tumour biopsy aimed at obtaining sufficient tissue for molecular profiling 3.2. Not willing/fit to have a tumour biopsy and had prior tumour molecular profiling 4. Patient deemed a suitable candidate for further systemic anti-cancer therapy 5. Willing and able to provide signed informed consent

Exclusion criteria

Does not meet the inclusion criteria

Locations

Related clinical trials

View on source registry