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Colonic Neoplasms clinical trials

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NCT ID: NCT02944188 Completed - Colon Cancer Clinical Trials

Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer

Start date: December 1, 2014
Phase: N/A
Study type: Interventional

In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.

NCT ID: NCT02942862 Completed - Colonic Neoplasms Clinical Trials

Evaluation of New Histoprognostic Criteria in a Retrospective Study of Colon Cancers Operated at Amiens University Hospital

Start date: February 2015
Phase: N/A
Study type: Observational

Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the pathological results. Histoprognostic new factors have recently been published by several authors, but their validity is still debated.

NCT ID: NCT02929186 Completed - Cancer of the Colon Clinical Trials

Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach

Start date: January 2017
Phase: N/A
Study type: Interventional

This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).

NCT ID: NCT02892721 Completed - Clinical trials for Colorectal Neoplasms

Performance and Evaluation for CT Colonography Screening

PERFECTS
Start date: April 20, 2017
Phase: N/A
Study type: Interventional

Colorectal cancer (CRC) is an important United Kingdom healthcare issue affecting 1 in 20 individuals, half of whom will die from the disease. Late presentation of CRC has a poor prognosis, whereas excellent cure rates (>95%) are seen in those who present early. Accurate and early diagnosis of CRC is therefore crucial. In most patients this is achieved via colonoscopy, a camera test which is widely available and allows tissue samples to be taken of any abnormalities seen during the procedure. However, a non-invasive alternative is Computed Tomography Colonography (CTC) which uses X-rays to produce images of the large bowel which are then interpreted by Radiologists. CTC has high sensitivity for the diagnosis of CRC (comparable to colonoscopy) and the cancer precursor - adenomatous polyps. Unlike colonoscopy, however, there is no accreditation process for CTC and there is no infrastructure to ensure that all reporting Radiologists are able to do so adequately and, as a result, there is a wide range of diagnostic accuracy. There are no universally-accepted standards to monitor quality or assess diagnostic performance, partly because we do not know what the quality markers are and there is currently no system to quantify them. Overall, this contributes to low cancer detection rates, missed cancers and inequity for patients across the National Health Service (NHS). This study aims to assess the impact of a structured training programme with assessment and feedback on NHS radiologist performance. If the impact is positive and results in significantly improved performance, then such a scheme could be adopted into an accreditation programme for CTC in the English Bowel Cancer Screening Programme (BCSP).

NCT ID: NCT02884024 Completed - Colorectal Cancer Clinical Trials

Effects of Weight on Inflammation and Colon Cancer Risk

Start date: January 2011
Phase: N/A
Study type: Observational

An observational study designed to compare colonic cytokine concentrations in lean versus obese individuals

NCT ID: NCT02850783 Completed - Sentinel Lymph Node Clinical Trials

SLN in Colon Cancer Using a Multimodal Tracer

Start date: March 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Lymph node status is the most important factor in the selection of patients for adjuvant chemotherapy after surgical treatment of primary colorectal carcinoma. Up to 30% stage I/II patients with negative lymph node involvement will develop distant metastases and eventually die from colorectal carcinoma (CRC). Better detection and pathologic staging of the lymph nodes could contribute to a better survival of colon cancer patients. This sentinel lymph node (SLN) procedure aims to identify the first draining lymph node(s) from the primary tumour, which have the highest risk of harbouring metastases. These SLNs can be pathological analysed with several more sensitive histopathologic techniques like immunohistochemical staining (IHC). Objective: Aim of this study is to investigate if the combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the sentinel lymph node mapping (SLNM) technique in colon cancer by utilizing the radioactive component for preoperative imaging (PET/CT) of the SLNs and the near infrared (NIR) fluorescence component for guidance to the SLNs during surgery. Study design: Single centre pilot study Study population: Ten patients with colon cancer (colon ascendens, colon transversum, colon descendens, sigmoid) stage Tis-T1-T2-T3, scheduled for laparoscopic surgical resection of the tumour. Intervention (if applicable): The present study will be performed with the radioactive tracer 89Zr-Nanocoll and fluorescent tracer Indocyanine Green (ICG). A colonoscopy will be performed to inject the radioactive tracer 48 hrs before surgery. After injection, patients will undergo the first PET/CT scan. A second PET/CT scan will be performed ± 24 hrs after tracer injection and a third scan just before the surgical procedure; ± 48 hrs after tracer administration. During the surgical procedure ICG diluted in saline and human albumin will be injected at the base of the tumour by colonoscopy. The PET/CT images will be compared with respect to the total number and location of foci and , if visible, lymphatic vessels. During surgery the fluorescent nodes will be marked with a suture in vivo. Thereafter the PET/CT images will be used as a roadmap, to detect SLNs which are not visible with the NIR laparoscope. These nodes will be marked with a suture too. When all radioactive and/ or fluorescent nodes are detected, the specimen will be resected like the conventional method. Ex vivo the specimen will be inspected for fluorescent and/or radioactive nodes not found in vivo. All the identified nodes will be taken out ex vivo and stored separately. The entire specimen will be submitted for pathologic examination. All identified SLNs will be stained with hematoxylin-eosin (H&E). If the fluorescent or radioactive SLNs are negative after routine H&E staining, they will be sliced in multiple parts and examined with H&E staining and immunohistochemistry with the specific marker CAM5.2. Finally, the pathologist uses palpation to identify the remaining non-fluorescent and/ or radioactive lymph nodes. Nodes found by palpation will be screened for fluorescent and/ or radioactive activity too. The amount of tumour tissue in positive nodes will be evaluated with the Q-prodit; an interactive video morphometry system (Leica, Cambridge, UK). Main study parameters/endpoints: Main study parameter is the identification rate of SLN mapping with preoperative PET/CT scans combined with intraoperative near-infrared (NIR) fluorescence imaging in patients with colon carcinoma. Thereby biodistribution and kinetics of 89Zr-Nanocoll have to be considered as primary study parameter. Secondary endpoints are the number and localization of the SLNs and optimal tracer volume. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participating patients will receive conventional resection of the tumour and follow-up according to normal standards in our hospital. The main goal of this study is to optimize the SLN mapping technique in colon cancer. If the investigators are able to identify the true SLN this could lead to better staging and survival of patients with this type of cancer. . Because of the colonoscopy ± 48 hrs before surgery, patients stay in the hospital will be prolonged with one day. The additional risks of exposure to radiation for participating patients are calculated and can be considered as negligible.

NCT ID: NCT02838186 Completed - Colon Neoplasms Clinical Trials

Backwards Examination of the Right Colon: A Back-to-back Study

Start date: May 2013
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the examination of the proximal colon with the retroflexion colonoscopic technique in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers.

NCT ID: NCT02834052 Completed - Solid Tumor Clinical Trials

Pembrolizumab + Poly-ICLC in MRP Colon Cancer

Start date: January 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this study is to determine the dose of poly-ICLC that is safe and tolerable when it is combined with pembrolizumab in patients with colon cancer. This study will also evaluate how the combination of pembrolizumab and poly-ICLC activates the immune system in the patient's blood and inside the tumor; how it affects the size and number of tumor(s) in each patient; and how effective the combination is in patients with colon cancer that is unlikely to respond to pembrolizumab alone.

NCT ID: NCT02792842 Completed - Clinical trials for Postoperative Stage II/III Colon Cancer

Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.

NCT ID: NCT02786602 Completed - Colon Cancer Clinical Trials

LRP1 Methylation and Colon Cancer

Start date: May 2016
Phase: N/A
Study type: Observational

Colorectal cancer (CRC) is a major public health problem in France and worldwide. CRC is the third most common cancer in incidence and mortality in France. The vast majority of these cancers are adenocarcinomas that arise sporadically and develop from precursor lesions: adenoma. All CRC with the same disease stage do not have the same prognosis. Various parameters have been identified as factors influencing the prognosis and allows adjustment of the treatment. The poor histoprognostic factors are vessels and nerves invasion by the tumor or the mucinous adenocarcinoma subtype. At the molecular level, the presence of microsatellite instability (MSI) improves the prognosis, while the presence of a BRAF mutation is an independent poor prognostic factor. The different molecular pathways of colonic carcinogenesis are the chromosomal instability pathway, the microsatellite instability pathway inducing errors in DNA mismatch repair and the CpG Island Methylator Phenotype (CIMP). The hypermethylation of CpG islands of genes promoters leads to an over or most frequently under gene expression. CIMP is observed in near 15% of CRC and is associated with specific clinical and pathological features: older patients, female predominance, right colonic involvement, poorly differentiated or mucinous adenocarcinomas. From a molecular point of view, the high CIMP phenotype is strongly associated with the presence of BRAFV600E mutation, the absence of RAS mutation and the presence of microsatellite instability. The prognostic value of CIMP is actually controversial. A recent meta-analysis found that the CIMP phenotype was associated with a poor prognosis. Methylation of some genes promoters as CDKN2A is associated with a poor prognosis. LRP-1 (low density lipoprotein receptor-related protein 1) is a multifunctional endocytic receptor that belongs to the LDL receptors the family. It mediates the clearance of many extracellular enzymes involved in the spread of cancer cells: metalloproteinases and serine proteinases. Decrease of LRP-1 activity or loss of LRP-1 expression correlates with increased aggressiveness of cancer cells in certain types of cancer. The expression of LRP-1 has almost never been studied in CRC. Only one immunohistochemical study of LRP-1 protein expression in colonic adenocarcinoma has been published to date. This study shows that tumor cells express LRP-1, but in nearly half the cases, weaker than in normal cells colic. The mechanisms involved in the decrease of expression are not known. An epigenetic mechanism might be involved as hypermethylation of the of LRP-1 gene promoter, especially as the promoter of this gene is rich in CpG islands (methylation targets). Clinical and prognostic significance of the LRP-1 gene expression and promoter methylation is actually unknown.