Dataset Information

Tissue and Blood-based Biomarker in Colorectal Cancer

ABSTRACT: Interventions: Collection and analysis of tissue and blood samples from patients diagnosed with colorectal cancer, benign bowel disease and healthy volunteers (no bowel pathology) for the purpose of investigating the potential use of novel non-invasive biomarkers for screening, detection of recurrence, predicting clinical outcome and response to therapies. Participants may be asked to give serial blood samples for the purposes of monitoring biomarker changes over time. These samples will be taken at the same time as routine clinical assessments to avoid inconvenience to the participant. The schedule for blood collections will therefore differ depending on which pathology the participant has, and which biomarker is being investigated. All such information will be supplied to the participant at the time of consent. Any tissue samples to be used will be retrospectively sourced from pathology laboratories, using tissue that was taken for clinical care outside of this project. All tissue supplied will be de-identified before testing by research laboratories. Follow up data will be collected from hospital records from a participants clinical visit. All participants, regardless of pathology, will be followed up for a total of five years from first consent. Retrospective data relative to the project may be collected from a participants medical record after consent has been signed. Primary outcome(s): Exploratory outcome looking at circulating tumour DNA changes using blood samples. [At time of diagnosis, recurrence, and in follow up after surgery. ];Disease response to systemic chemotherapy and/or biologic agents determined by CT imaging [At time of diagnosis, recurrence, and in follow up after surgery.];Correlating DNA polymorphisms with protein/cytokine biomarkers[serial bloods (e.g. at 3, 6 or 18 months) after surgery and at recurrence.] Study Design: Purpose: Screening;Duration: Longitudinal;Selection: Convenience sample;Timing: Both

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

PROVIDER: 2472569 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Individuals with stage IV colorectal cancer who are planned to undergo surgery to remove their primary tumour +/- metastatic disease as part of their routine cancer care will be recruited to this study. At the time of surgery, once the specimen has been surgically resected, a number of fresh tissue samples will be obtained from the specimen for the research study. These samples will include lymph nodes, a small sample of the primary tumour, a sample of normal tissue, and a sample of a metastasis. These samples will be obtained by a senior colorectal surgeon under the supervision of pathology staff. In addition, a blood sample (up to 40ml) will be taken from the participant via their routinely inserted peripheral vein cannula once the participant is under general anaesthesia or at the appropriate time prior to surgery co-ordinated with diagnostic sampling by the anaesthetist. Samples obtained will be processed for single cell RNA sequencing analysis. Remaining tissue, cells and plasma that have been isolated from tissue and blood will be cryopreserved and stored in a secure manner. Participants will not be required to attend any follow up study visits for this study. The Peter MacCallum Cancer Centre hospital electronic medical record will be reviewed from time of initial diagnosis up to 3 years post-surgery for all participants who choose to enrol. Only relevant clinical data regarding the participant will be obtained and stored in a secure and de-identified manner. This will include basic demographics, diagnosis, stage and site of primary tumour, site(s) of metastatic disease, prior anti-cancer treatment, relapse date, death date and follow up dates, past and concurrent medical history, and concurrent medications at time of surgery. Primary outcome(s): Identification of a lymph node restricted CD8+ T cell population with a gene expression profile consistent with peripheral tolerance using single cell RNA sequence (scRNAseq) analysis of all obtained samples.[At completion of scRNAseq analysis of all obtained samples] Study Design: Timing: Prospective

Project description:BACKGROUND & AIMS: In approximately 70% of patients with hepatocellular carcinoma (HCC) treated by resection or ablation, disease recurs within 5 years. Although gene expression signatures have been associated with outcome, there is no method to predict recurrence based on combined clinical, pathology, and genomic data (from tumor and cirrhotic tissue). We evaluated gene expression signatures associated with outcome in a large cohort of patients with early stage (Barcelona-Clinic Liver Cancer 0/A), single-nodule HCC and heterogeneity of signatures within tumor tissues. METHODS: We assessed 287 HCC patients undergoing resection and tested genome-wide expression platforms using tumor (n = 287) and adjacent nontumor, cirrhotic tissue (n = 226). We evaluated gene expression signatures with reported prognostic ability generated from tumor or cirrhotic tissue in 18 and 4 reports, respectively. In 15 additional patients, we profiled samples from the center and periphery of the tumor, to determine stability of signatures. Data analysis included Cox modeling and random survival forests to identify independent predictors of tumor recurrence. RESULTS: Gene expression signatures that were associated with aggressive HCC were clustered, as well as those associated with tumors of progenitor cell origin and those from nontumor, adjacent, cirrhotic tissues. On multivariate analysis, the tumor-associated signature G3-proliferation (hazard ratio [HR], 1.75; P = .003) and an adjacent poor-survival signature (HR, 1.74; P = .004) were independent predictors of HCC recurrence, along with satellites (HR, 1.66; P = .04). Samples from different sites in the same tumor nodule were reproducibly classified. CONCLUSIONS: We developed a composite prognostic model for HCC recurrence, based on gene expression patterns in tumor and adjacent tissues. These signatures predict early and overall recurrence in patients with HCC, and complement findings from clinical and pathology analyses. Center and peripheral portions of hepatocellular carcinoma tumors as well as surrounding non-tumor cirrhotic liver tissues were obtained from fresh frozen surgically resected tissues, and isolated total RNA samples were analyzed for genome-wide expression profiles.

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Tissue and Blood-based Biomarker in Colorectal Cancer

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