Canadian Colorectal Cancer Consortium
Scope: To establish a high-risk colorectal cancer (CRC) registry throughout Canada by collecting data and biospecimens on individuals with newly diagnosed CRC under the age of 60.
Background: This study will look at the genetic components of CRC, including screening for a well-known hereditary CRC condition, Lynch Syndrome. Relatives of CRC patients will also be invited to participate in the study to analyze colonoscopy participation rates, and DNA from high risk families who are not found to have a known hereditary cancer syndrome will provide an invaluable resource for CRC gene discovery studies using next-generation sequencing.
Objective: Through this study, we are hoping to improve screening programs and increase colonoscopy rates in high-risk individuals. Furthermore, the potential identification of novel genes associated with hereditary CRC could provide opportunities for better screening and early detection of CRC in at-risk individuals and improve survival in the second leading cause of cancer death in Canada
Cook Myosite – Gastrointestinal Fecal Incontinence (GIFI)
Scope: To test the safety and feasibility of Autologous Muscle Derived Cells (AMDC) as a treatment for fecal incontinence in men and women. AMDC therapy seeks to allow remodeling of the anal sphincter in patients with fecal incontinence from either defined structural defects to, or a generalized weakening of, the anal sphincter.
Background: This treatment is hypothesized to reduce symptoms of fecal incontinence and improve patient quality of life by strengthening the anal sphincter muscle. The procedure uses Cook MyoSite Incorporated AMDC. AMDC are muscle progenitor cells isolated from a patient’s skeletal muscle. The tissue is collected from a muscle biopsy done on the patient’s thigh and sent to the manufacturer for processing. The resulting cells are sent back to the physician who injects the cells into the patient’s anal sphincter in an outpatient procedure using a small needle under direct vision. Endoanal ultrasound may be used at the physician’s discretion to visualize the location of the injection needle within the anal sphincter.
Objective: The study is a prospective nonrandomized study and will treat a total of 50 patients. The primary objective is to determine the incidence of product or procedure related adverse events associated with the use of AMDC. The secondary outcome objectives are to study the effect of AMDC treatment for fecal incontinence. Patients will be followed for 12 months.
Scope: QuickSilver is a pan-Canadian study aimed at improving treatment options and outcomes in rectal cancer care.
Background: Currently, pre-operative chemoradiotherapy (preCRT) is recommended for Stage II and Stage III rectal cancer because preCRT reduces the risk of local recurrence from 15% to 7.5% at two years. Unfortunately, while preCRT reduces the risk of local recurrence, it does not improve survival, leads to significantly poorer bowel and sexual function and may increase the risk of developing second malignancies compared to surgery alone.
Objective: QuickSilver is a prospective study to identify "good prognosis" Stage II and Stage III cancer patients for primary surgery using MRI criteria. The study will evaluate a new approach to improve the selection and limit the use of preCRT in Stage II and Stage III rectal cancer patients and improve long term bowel and sexual function.
CPAC Rectal Cancer Project
Scope: The Canadian Partnership Against Cancer (CPAC) Rectal Cancer Project is a multi-year project designed to improve the clinical outcomes for patients by implementing quality initiatives for rectal cancer across Canada.
Background: The implementation of these quality initiatives will be evaluated using a set of quality indicators developed for the study, which report the level at which these quality indicators are achieved. Additional site specific knowledge translation strategies will be used to further enhance the implementation of these quality initiatives at each individual site.
Objective: This project is highly relevant as successful widespread implementation of these quality initiatives will lead to improved and more standardized rectal cancer care and set a national standard for these quality initiatives across Canada.
Cook Hernia – AMEX
Scope: This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.
Background: The Cook® Antimicrobial Hernia Repair Device is made of a biologic material derived from a porcine source that contains a controlled volume of an antibiotic called gentamicin sulfate. It is intended to be implanted to reinforce soft tissue where weakness exists. The indications for use include the repair of a hernia or a body wall defect.
Objective: The primary outcome measure of this study is the incidence of surgical site infection in study patients at six months. The secondary outcome measure of this study is incidence of procedural or post-operative adverse events related to the study device or procedure (e.g., permanence of hernia repair, as determined by hernia recurrence) at 12 months.
(Detection and Neurological impact of cerebroVascular events In noncardiac Surgery PatIents: A cOhort evaluatioN Study)
Scope: The NeuroVISION Study is a multicentre prospective cohort study, which will enroll 1500 patients who are ≥65 years of age and are anticipated to require a ≥2 night hospital stay after noncardiac surgery.
Background: Covert (minor) strokes occur in a small sample of the population (~0.5%) undergoing surgery. Many of these strokes go undetected as they occur without symptoms.
This study is seeking to identify the incidences as well as the long term impacts of these covert strokes. We will determine the incidence of acute covert stroke using an MRI study of the brain in the days following noncardiac surgery.
Objective: The primary objective of the NeuroVISION study is to characterize the impact of postoperative covert stroke on neurocognitive function one year after elective noncardiac surgery.