None listed
Conditions
Brief summary
This study is to evaluate the potential of tumour organoid response to predict the clinical benefit that individual patients will derive from available anti-cancer therapies for advanced CRC, in the first- and later-line therapy settings. Who is it for: You may be eligible for this study if you are an adult male or female with a diagnosis of CRC that is either locally advanced and unresectable, or metastatic, have not received treatment (ie chemotherapy) for this stage of disease and otherwise are fit enough to undertake treatment. Study details: The study will involve obtaining biopsies initially and at time of progression and using standard and novel blood tests. The consistency of results between expanded panel (TSO500) based testing of tumour tissue and laboratory-based profiling of the matched PDTO will be examined. It is hoped that these results will help improve decision making by clinicians and ultimately individualise patient's treatment to improve outcomes. Patients will receive standard of care treatment at the discretion of their Oncologist. (this is standard practise, done for those not participating in clinical trials also). It is hoped that findings from this study will establish reliable preclinical models that will enable high throughput drug testing to guide optimal treatment selection in daily clinical practice in the future, and potentially inform treatment selection of standard of care agents in first and later line treatment.
Interventions
The study will collect fresh tumour biopsies from sites of metastases (liver metastases if possible) or the colorectal primary, in patients with treatment-naive, locally advanced and unresectable mCRC, at baseline and disease progression- (can't predict timeframe for progression-determined by radiological growth or clinical symptoms). This will be done via a core-needle or excisional biopsy, or open surgical procedure ,by surgeon or radiologist. It is for the purpose of generating a patient deri
The study will collect fresh tumour biopsies from sites of metastases (liver metastases if possible) or the colorectal primary, in patients with treatment-naive, locally advanced and unresectable mCRC, at baseline and disease progression- (can't predict timeframe for progression-determined by radiological growth or clinical symptoms). This will be done via a core-needle or excisional biopsy, or open surgical procedure ,by surgeon or radiologist. It is for the purpose of generating a patient derived tumour organoid (PDTO) culture. PDTO will be used to test 10-12 drugs. At the same time as biopsy, 30 - 60mL of whole blood will also be collected for the purposes of germline genomic evaluation, ctDNA analysis and collection of PBMC for co-culture with PDTO. This will be collected by pathology department or a delegated nurse.. The aim is to establish reliable preclinical models that will enable high throughput drug testing to guide optimal treatment selection in daily clinical practice in the future, and potentially inform treatment selection of standard of care agents in first and second-line treatment and beyond.
Sponsors
Walter and Eliza Hall Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1 Be able to provide informed, voluntary, written consent. 2 Have a diagnosis of CRC that is either locally advanced and unresectable, or metastatic. 3 Have ECOG performance status of 0-2. 4 Have adequate major organ function. 5 Be fit to receive systemic treatment. 6 Be planning to receive systemic treatment. 7 Have chemotherapy-naïve disease in the advanced setting. Prior chemotherapy in the neo/adjuvant setting is permitted for those with relapsed disease. 8 Have a life expectancy of > 3 months. 9 Be accessible for follow up and data collection. 10 Be willing and able to undergo initial tumour biopsy and provide serial blood samples. 11 Be willing to provide archival tumour tissue or fresh tumour tissue for genetic testing
Exclusion criteria
1 Cannot undergo biopsy of tumour tissue either due to patient factors (such as being unable to withhold anticoagulation) or tumour factors (location, size inappropriate to biopsy). 2 Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 3 Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study.
Outcome results
None listed