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Colonic Neoplasms clinical trials

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NCT ID: NCT05500248 Recruiting - Colonic Neoplasms Clinical Trials

Artificial Intelligence for Leaving in Situ Colorectal Polyps.

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting. With this study it will be possible to understand the impact of CADx in patient treatment and management both in terms of clinical outcome and costs.

NCT ID: NCT05498051 Completed - Clinical trials for Colorectal Neoplasms

Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.

IBIZA-1
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using peritumoral submucosal injections

NCT ID: NCT05497726 Completed - Clinical trials for Colorectal Neoplasms

Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Intravenous Bevacizumab-800CW

IBIZA-2
Start date: January 27, 2023
Phase: N/A
Study type: Interventional

This prospective study aims to assess the safety and feasibility of lymph node identification using bevacizumab-800CW in patients with cT1-3N0-2 tumours, using intravenous administration.

NCT ID: NCT05495048 Recruiting - Colon Cancer Clinical Trials

Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.

NCT ID: NCT05493033 Not yet recruiting - Colon Cancer Clinical Trials

Intracorporeal Versus Extracorporeal Anastomotic After Laparoscopic Right Colectomy

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Background: Laparoscopic assisted right hemicolectomy is recommended for right colon cancer. As a more minimally invasive procedure, intracorporeal ileocolic anastomosis has potential advantages: reducing torsion and traction on the mesentery, reducing skin incision length and enhancing postoperative recovery. However, the longer operative time, greater risk of intra-abdominal infection and steep learning curve for intestinal anastomosis performed under laparoscopic conditions, does this increase the incidence of postoperative complications, especially the incidence of anastomotic leakage, and whether it affects There is no high-level research evidence on the survival of patients. Study design: COlOR IV study is an international prospective, multicenter, randomized controlled clinical study of intraperitoneal anastomosis versus extraperitoneal anastomosis after laparoscopic right hemicolectomy for colon cancer . The study will include a quality assessment phase before randomisation to ensure required competency level and uniformity of the intracorporeal and extracoporeal techniques. Endpoint: Primary outcome is anastomotic leakage within 30 days after surgery. Main secondary endpoint is 3-year disease-free survival rate. Secondary endpoints are mortality and morbidity, postoperative recovery, overall survival, surgical specimen quality, quality of life. Statistics: The primary endpoint is anastomotic leakage within 30 days after surgery. The anastomotic leakage rate was set to 2% in the both groups, and an increase in the incidence of anastomotic leakage of 2.5% was considered inferior. The one-sided significance level was 0.025, the power was 0.9. The dropout rate was 20%, and taking into account the post-randomization analysis (dropout 5%), the total sample size was 1158. There were 579 cases in the intracorporeal anastomosis group and 579 cases in the extracorporeal anastomosis group. Main selection: Patients with histologically proven right colon cancer (cecum, ascending colon and proximal 1/3 of the transverse colon malignant tumor), clinically stage I-III, and intention for right hemicolectomy with primary anastomosis. Hypothesis: The hypothesis is that intracoporeal anastomosis will have comparable anastomotic leak rate and 3-year DFS, but faster postoperative recovery with extracoporeal anastomosis.

NCT ID: NCT05482516 Recruiting - Clinical trials for Hepatocellular Carcinoma

Evaluating Novel Therapies in ctDNA Positive GI Cancers

MRD-GI
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

This 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.

NCT ID: NCT05475288 Completed - Colonic Neoplasms Clinical Trials

Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer

Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locoregionally recurrent colon cancer were determined.

NCT ID: NCT05472753 Recruiting - Colon Cancer Clinical Trials

Dietary Supplement on the Intestinal Microbiota in Patients With Colon Cancer

TERATROFO
Start date: November 16, 2022
Phase: N/A
Study type: Interventional

Effect of a dietary supplement with antioxidant and anti-inflamatory properties on the intestinal microbiota in patients with colon cancer. Ramdonized placebo controlled clinical trial. Teratrophic study

NCT ID: NCT05468827 Recruiting - Colon Cancer Clinical Trials

ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer

ISCAPE
Start date: July 26, 2022
Phase: N/A
Study type: Interventional

The study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination

NCT ID: NCT05468177 Recruiting - Colonic Neoplasms Clinical Trials

Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Right-Sided Colon Cancer

CIFOXRC
Start date: August 1, 2022
Phase: Phase 2
Study type: Interventional

We plan to evaluate the efficacy and safety of cetuximab combined with anti-PD-1 and mFOLFOX6 in the treatment of RAS/BRAF WT locally advanced or metastatic right colon cancer