None listed
Conditions
Brief summary
This feasibility study aims to determine whether a drug screening model can be created using tumour cells from patients with metastatic colorectal cancer that have not been responsive to previous treatments. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with metastatic colorectal cancer (cancer that has spread to another part of the body) that has so far been unresponsive to or has progressed through other cancer treatments. Study details Participants in this study will undergo a tumour biopsy procedure. For this procedure, a tissue sample will be taken under radiological imaging, by an experienced doctor. The tissue sample will then be used in laboratory tests by the research team to determine how the cells react to different types of drugs. Participants will also have information about their specific disease characteristics, treatments administered and the outcome of each treatment collected by their doctor as is usual practice. This information will also be shared with the research team to further their understanding of disease-drug interactions. It is hoped this research may be used to improve health outcomes for future patients with metastatic colorectal cancer by determining whether it is possible to create a specific tumour cell drug screening model to test the effectiveness of cancer drugs.
Interventions
This feasibility study involves the collection of fresh tumour tissue from patients with Metastatic Colorectal Cancer ( mCRC) for the purposes of establishing organoid model cultures.Participants will be asked to provide up to 3 tumour tissue samples(depending on size of the tumour) from a once only biopsy. This as an above standard of care, separate procedure. The mode of biopsy will be dependent on the site metastatic disease. Radiological imaging will be used to locate the secondary cancer si
This feasibility study involves the collection of fresh tumour tissue from patients with Metastatic Colorectal Cancer ( mCRC) for the purposes of establishing organoid model cultures.Participants will be asked to provide up to 3 tumour tissue samples(depending on size of the tumour) from a once only biopsy. This as an above standard of care, separate procedure. The mode of biopsy will be dependent on the site metastatic disease. Radiological imaging will be used to locate the secondary cancer sites, for example an ultrasound or CT scan.The biopsy will be performed by an interventional radiologist . The biopsy process is anticipated to take a 1 hour, though may vary depending on the site of disease. 20 mls of blood will be required from participants; the equivalent of 2 tablespoons. It is planned that this blood will be drawn at the biopsy visit. Two visits to hospital are required, for informed consent discussion and for the biopsy itself. These tumour samples will be used to develop patient derived tumour organoids (PDTO) or mini tumours. The PDTO will be used is to develop a drug sensitivity testing to predict therapeutic response. This drug sensitivity reports are a research outcome, they are not validated or accredited and cannot be used as a recommendation for further treatment of the subject. The therapeutic drug responses in these models with will be collated with detailed clinic-pathological, treatment and the clinical outcomes data for participants. This data will be collected from medical records or requested from referring physicians.
Sponsors
Australasian Gastro-Intestinal Trials Group (AGITG)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to provide informed, voluntary, written consent 2. Have a diagnosis of metastatic colorectal cancer 3. Are able to safely undergo biopsy to provide samples of fresh tumour 4. ECOG performance status of 0-2 5. Have adequate major organ function 6. Fit for further systemic treatment 7. Have failed or are intolerant of standard therapies (excluding trifluridine/tipiracil) 8. Prior systemic treatment must have discontinued at least 2 weeks prior to enrolment onto the study 9. Have a life expectancy of > 3 months 10. Are accessible for follow up and de-identified coded data collection
Exclusion criteria
1. Have a condition that interferes with their ability to provide informed consent or comply with the protocol 2. Unable to provide tissue samples for any reason
Outcome results
None listed