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Colonic Neoplasms clinical trials

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NCT ID: NCT03881332 Completed - Rectal Cancer Clinical Trials

Measurement of Perioperative Glomerular Filtration Rate

Start date: December 26, 2019
Phase:
Study type: Observational [Patient Registry]

Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

NCT ID: NCT03871790 Completed - Pancreatic Cancer Clinical Trials

Peptide-based Immunization for Colon- and and Pancreas-carcinoma

PICOP-GLOBAL
Start date: April 1, 2019
Phase:
Study type: Observational

An international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.

NCT ID: NCT03863236 Recruiting - Colon Cancer Clinical Trials

A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This is a multicenter, unblinded, randomized study. The aim of this study is to research whether preoperative and postoperative oral nutritional supplement (ONS) (Resource 2.5 Compact/fibre compact) used at least 2 weeks prior the surgery and 10 days after surgery can improve the nutritional status of a colon cancer patient and reduce number of complications. The aim is also to investigate whether the oral nutritional support can shorten the hospital stay and improve the patients´ quality of life. The aim is also to find out whether the oral nutritional support can reduce 90-day mortality and improve disease free and overall survival. Consecutive patients diagnosed with primary adenocarcinoma of the colon who are considered for radical surgical procedure are enrolled in this study provided that the inclusion criteria are filled. Patients in the intervention group start oral nutritional support (ONS)2 portions a day for about 2 weeks prior to the operation starting at the time of randomization and continue ONS 10 days after the operation. Control group will continue with their regular diet without ONS until the operation. Both groups keep a food diary for 4 days right after the randomization and both one month and three months after the operation to assess the energy and nutrient intakes. Laboratory markers, NRS 2002, quality of life questionnaire, exercise questionnaire, bioelectrical impedance analysis (BIA) and handgrip strength as well as body composition on computer tomography scan are assessed prior to any treatment or supplement in order to estimate the patients' well-being and nutritional status prior to surgical operation. Laboratory parameters and QoL questionnaire are repeated right before the operation on admission to hospital as well as about 30 and 90 days after the operation in addition to BIA, handgrip strength to assess the effect of nutritional support. Data on complications, infections, length of stay in the hospital and mortality are collected. Another arm in this research is to discover more information on biological markers in colon cancer and cancer related malnutrition thus providing targets for future treatment and prognostic predictors. Tissue samples are collected during this research at the surgery.

NCT ID: NCT03853473 Completed - Surgery Clinical Trials

Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning

Prehab
Start date: February 22, 2019
Phase: N/A
Study type: Interventional

This project will examine the efficacy of a simple, cost-effective, non-invasive intervention, called remote ischemic preconditioning (RIPC), to reduce frailty in pre-surgical, frail, elderly patients with colon cancer. The investigators hypothesize that RIPC will reduce frailty in the pre-surgical period (as assessed by distance walked during the 6-minute walk test), improve functional capacity 4-weeks postoperatively, and reduce intraoperative blood pressure variability. If successful, future studies will examine the efficacy of RIPC to improve surgical outcomes in frail cancer patients.

NCT ID: NCT03852290 Active, not recruiting - Colon Cancer Clinical Trials

C677T and A1298C MTHFR Polymorphisms and Fluoropyrimidine Effectiveness in Metastatic Colon Cancer

Start date: January 16, 2019
Phase:
Study type: Observational

Fluoropyrimidines are the backbone of chemotherapy regimes used to treat metastatic colorectal cancer (CRC). These drugs act in different pathways of folate metabolism altering DNA synthesis mainly by inhibition of the tymidylate synthase. For this reaction the 5,10-methylenetetrahydrofolate acts as cofactor. It has been demonstrated that A1298C and C677T polymorphisms in the methylenetetrahydrofolate reductase (MTHFR) gene result in reduced enzyme activity that leads to reduced availability of this important cofactor. Hence, we hypothesized that the presence of these polymorphisms are related to the efficacy and toxicity of fluoropyrimidines in patients with CRC.

NCT ID: NCT03827967 Completed - Colon Cancer Clinical Trials

Trial of PalloV-CC in Colon Cancer

Start date: July 20, 2019
Phase: Phase 1
Study type: Interventional

This study is a phase Ib prospective, open label study evaluating the effect of vaccination on the immune microenvironment of cancers with results compared to banked tissue from historical controls. Prospectively vaccinated patients will also serve as their own controls by comparing the immune microenvironment of the tumor in pre-treatment biopsies to post-treatment surgical specimens. This is also a dose-escalation study with consecutive enrollment and advancement of cohorts in an overlapping fashion.

NCT ID: NCT03827044 Terminated - Clinical trials for Stage III Colon Cancer

Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer

POLEM
Start date: August 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if dMMR and/or POLE exonuclease domain mutant stage III colon cancer patients gain clinical benefit (i.e. improvement in disease free and overall survival) from PD-L1 inhibitors after standard fluoropyrimidine-based adjuvant chemotherapy. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effects of PD-L1 on anti-tumour CD8+ T cells, resulting in the restoration of cytotoxic T cell response. The rationale of giving Avelumab after standard adjuvant chemotherapy to this well-defined, molecularly-selected, group is based on the fact that dMMR and POLE exonuclease domain mutant CRCs have a highly and ultra-mutated genetic profile, respectively, thus leading to a high number of neo-antigens with associated over expression of immune checkpoint related proteins. This profile is expected to be highly responsive to checkpoint inhibition as suggested by data of PD-1 inhibitors in dMMR/MSI-H metastatic CRCs. If this study meets the primary endpoint, using Avelumab in the adjuvant setting following standard chemotherapy would become the standard of care for patients with dMMR and/or POLE exonuclease domain mutant colon cancers. Furthermore, given the availability of molecular markers for patient selection, funders of healthcare would be more likely to fund this treatment. This study also provides a unique opportunity to conduct translational research analyses on pre- and post-treatment tumour tissue samples and blood samples from dMMR or POLE mutant CRC patients treated with the checkpoint inhibitor Avelumab.

NCT ID: NCT03826446 Completed - Colon Cancer Clinical Trials

Laparoscopic Versus Open Complete Mesocolic Excision With Central Vascular Ligation in Right Colon Cancer

Start date: January 13, 2016
Phase: N/A
Study type: Interventional

Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon.The aim of this study was to compare between laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.

NCT ID: NCT03816774 Completed - Colonic Neoplasms Clinical Trials

Effect of Adding Simethicone to Split-dose Polyethylene Glycol for Bowel Preparation in a Screening Colonoscopy Setting

Start date: June 15, 2019
Phase: N/A
Study type: Interventional

Colonoscopy is currently accepted as the gold standard in screening, surveillance and prevention for colorectal cancer (CRC), and therefore, its quality is a major priority. The quality of colonoscopy is greatly dependent on the quality of the bowel preparation. Standard bowel cleansing includes a low-fibre diet on the day preceding the exam and a split regimen of 4 litres of polyethylene glycol (PEG) solution. In order to improve bowel cleansing some additional measures are available. Simethicone is an inexpensive and safe antifoaming agent that reduces the surface tension of air bubbles, theoretically presenting several benefits such as increased tolerability to the preparation, thereby improving the quality of the preparation and, secondly, adenoma detection (ADR) and cecal intubation rates (CIR). However, its role remains controversial, with some publications supporting its administration and others failing to demonstrate clear benefits. The main aim of this study is to assess if addition of simethicone to a split-dose cleansing regimen of 4 litres of PEG improves adequate bowel preparation rate.

NCT ID: NCT03814369 Completed - Colonic Neoplasms Clinical Trials

AmplifEYE Colonoscopy vs Standard Colonoscopy

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a row of flexible detection arms attached to the tip of colonoscope which can separate colonic folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical data on this relatively new device is lacking and this study aims to compare the adenoma and polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.