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FORECAST 1. Feasibility of using Organoid Response to find Effective Treatments for patients with Colorectal cancer After failure of Standard Therapy


ABSTRACT: 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 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. Primary outcome(s): Feasibility will be assessed based on the number of PDTO successfully established for high throughput drug screening to guide clinical decision making. [4- 6 weeks post collection of biopsy] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

DISEASE(S): Metastatic Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2471568 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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