Comparison of Limb Size of Transverse Coloplasty Pouch
Colon CancerThe aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.
Evaluating Novel Therapies in ctDNA Positive GI Cancers
Colon AdenocarcinomaRectal Adenocarcinoma5 moreThis study is a non-randomized, open-label, multi-cohort, multi-site, pilot feasibility therapeutic trial. The study will enroll 20 patients across 4 cohorts (CRC, gastric, PDAC, and HCC/intra-hepatic-/extra-hepatic-, gall bladder adenocarcinomas) diagnosed with histologically confirmed GI cancers. These patients will have already completed all Standard of Care (SOC) treatments (including neoadjuvant, surgery, local therapies, and/or adjuvant therapy as applicable), as defined by the treating primary physician or research team, with curative intent but have a positive SignateraTM tumor-informed ctDNA test and NED radiographically by standard imaging within 28 days prior to enrollment and within 1 year of completing all curative-intent therapy. All patients will be treated with intravenous (IV) atezolizumab 1200 mg IV and bevacizumab 15 mg/kg on Day 1 of 21-day cycles until disease recurrence, ctDNA POD, unacceptable toxicity, or subject withdrawal of consent with a maximum 12 month total duration of study therapy. Atezolizumab and bevacizumab drug will be provided.
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel...
Colon CancerThe purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in...
Colonic NeoplasmsThis three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.
Second and Third Look Laparoscopy in pT4 Colon Cancer Patients for Early Detection of Peritoneal...
Colorectal CancerPeritoneal MetastasesThe COLOPEC II multicentre randomized trial will investigate the role of second and third look laparoscopy to detect metachronous peritoneal metastases at a clinically occult stage during the follow-up of pT4 colon cancer patients. It is expected that detection of PM at a clinically occult stage will translate into survival benefit, due to higher percentage of patients eligible for curative intent treatment with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC).
Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients...
Colorectal CancerColo-rectal Cancer13 moreIMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.
ExPECT: Extraperitoneal End Colostomy Trial
Colostomy StomaCancer of Colon2 moreA randomised controlled feasibility study to compare two surgery techniques in the formation of a permanent end colostomy; the trans-peritoneal(TP) technique - currently, the most commonly used technique and the investigational extra-peritoneal(EP) technique, which has been reported in small studies to reduce the risk of parastomal hernia . This feasibility study will primarily aim to determine the feasibility viability of progression to a full multi-centre trial and test study design acceptability for participants. Participants will be asked to consent to be randomised to either the TP or EP procedure during surgery. Following surgery, participants will be followed up to a maximum of 12 months and asked to complete quality of life questionnaires (EQ5D and Colostomy Impact Score). Participant data will also be accessed by research teams at site to collect data on stoma appliance use and complications.
Anesthesia and Cancer Study: Colon Cancer
Cancer of ColonAnesthesiaThis study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.
Enhancing Cancer Prevention and Control Pathways-Native Health Initiative
CancerBreast4 moreThere are continued disparities in cancer incidence, mortality, and survival between American Indians (AIs) and Whites on cancers responsive to early screening (i.e., breast, colorectal, and cervical) in the US. In New Mexico (NM), AIs compared with other racial/ethnic populations are significantly less likely to adhere to recommended screening guidelines. The purpose of this trial is to develop and pilot test multilevel/multicomponent intervention strategies to enhance screening for breast, colorectal, and cervical cancers.
EPA for Metastasis Trial 2
Liver MetastasisColon CancerA significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to the liver (metastases) develop disease recurrence and die from the disease. A previous small study (the EMT study) suggested a possible survival benefit in patients who took the naturally-occurring omega-3 fatty acid EPA (a fish oil supplement) before liver surgery. The EMT2 study is a larger study which will recruit 448 men and women with liver metastases from bowel cancer. Trial participants will receive either Icosapent Ethyl (pure EPA derived from fish oil) or placebo (dummy capsules). EMT2 will investigate whether patients who take this supplement before liver surgery and for up to four years after surgery, remain free of recurrence for longer than those who take placebo (dummy capsules)