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In colorectal metastases patients who require liver resection, does a surgeon having knowledge of liver fat measurements influence surgical planning decisions that result in improved patient outcomes.

ABSTRACT: Intervention arm – the surgeon will have knowledge of a quantitative measure of liver fat from MRI (HepaFat-Scan) Primary Outcome 1: all cause mortality as assessed by data linkage to medical records[Timepoint: within 3 months post surgery];Primary Outcome 2: postoperative complications as assessed by data linkage to medical records (e.g. ascites, urine infection, bilioma, renal failure)[Timepoint: at baseline and 6 months post surgery];Primary Outcome 3: deviations from standard surgical treatment as assessed by qualitative questionnaire designed specifically for this study[Timepoint: baseline] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy

DISEASE(S): Surgery-surgical Techniques,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Resection Of Colorectal Liver Metastases,Cancer-liver

PROVIDER: 2462248 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: This is a prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from two distinct cohorts of patients: COHORT A: Patients with curatively resected stage II colon cancer- subgroups will be enrolled according to whether adjuvant chemotherapy is recommended by patient’s treating oncologist. Group A - Chemotherpay; Group B - No Chemo (serial blood collection) and Group C - No chemotherapy (baseline sample). Timepoints for each group in COHORT A are as follows: Group A - 60mls of blood will be collected at 11 timepoints- Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint 2 - Post 3 month of chemotherapy Timepoint 3 - Completion of chemotherapy Timepoint (4 - 11) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group B - 60mls of blood will be collected at 9 timepoints - Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint (2 - 9) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group C - 60mls of blood will be collected at 1 timepoint - Timepoint 1 Baseline (4-8 weeks post operation) COHORT B - Patients with metastatic (stage IV) colorectal cancer undergoing first line chemotherapy. 60 mls of blood will be collected at 3 timepoints - Timepoint 1 - Priot to Cycle 1 Day 1 chemotherapy Timepoint 2 - Cycle 1 Day 3 chemotherapy Timepoint 3 - Cycle 2 Day 1 cemotherapy Primary outcome(s): COHORT A Stage II Colrectal Cancer - to demonstrate that persistence of tumour derived DNA in peripheral blood following complete resection of the primary tumour is a sensitive and specific arker of subsequent disease recurrence.[COHORT A - At the completion of the analysis of blood, plasma and tissue samples. COHORT A are as follows: Group A - 60mls of blood will be collected at 11 timepoints- Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint 2 - Post 3 month of chemotherapy Timepoint 3 - Completion of chemotherapy Timepoint (4 - 11) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group B - 60mls of blood will be collected at 9 timepoints - Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint (2 - 9) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group C - 60mls of blood will be collected at 1 timepoint - Timepoint 1 Baseline (4-8 weeks post operation)];COHORT B Stage IV Colorectal Cancer - To confirm that early changes in the level of circulating tumour DNA are a sensitive and specific marker of treatment response or resistance.[COHORT B - At the completion of the analysis of blood, plasma and tissue samples. COHORT B - Patients with metastatic (stage IV) colorectal cancer undergoing first line chemotherapy. 60 mls of blood will be collected at 3 timepoints - Timepoint 1 - Priot to Cycle 1 Day 1 chemotherapy Timepoint 2 - Cycle 1 Day 3 chemotherapy Timepoint 3 - Cycle 2 Day 1 cemotherapy] Study Design: Timing: Prospective

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In colorectal metastases patients who require liver resection, does a surgeon having knowledge of liver fat measurements influence surgical planning decisions that result in improved patient outcomes.

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