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Colorectal Adenoma clinical trials

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NCT ID: NCT04797065 Completed - Colorectal Adenoma Clinical Trials

9 Minutes for Tandem Colonoscopy Withdrawal

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.

NCT ID: NCT04723758 Completed - Colorectal Adenoma Clinical Trials

COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.

NCT ID: NCT04693546 Not yet recruiting - Colorectal Cancer Clinical Trials

Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening

PREVENT
Start date: June 2021
Phase:
Study type: Observational

The purpose of this study is to determine the sensitivity and specificity for LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer (CRC) and for adenoma, including advanced adenoma.

NCT ID: NCT04636619 Recruiting - Colorectal Cancer Clinical Trials

Clinical Trial Evaluating External Evaluation and Training on the Incomplete Resection (POLIPEVA Study)

POLIPEVA
Start date: March 12, 2021
Phase: N/A
Study type: Interventional

Introduction It has been shown that some quality indicators in endoscopy can be improved through educational interventions. There are marked differences in the proportion of incomplete polypectomies among endoscopists. The effectiveness of measures to improve it has not been evaluated. Objective The main objective is to evaluate whether a training intervention or the notification of the individual proportion of incomplete polypectomies (those in which post-polypectomy biopsies of the resection margin show tissue other than normal mucosa) can improve this proportion. As secondary objectives, we will compare the proportion of fragmented polypectomies and adverse events. We will evaluate the factors associated with incomplete excision or failed cold polypectomy, as well as the individual evolution of the participants. Methods Non-pharmacological clinical trial involving endoscopists with> 1 year of experience and patients scheduled for colonoscopy. After each polypectomy, 2 additional biopsies will be taken and evaluated centrally by a blind pathologist. In a first phase, the basal rate of the participants will be evaluated. After it, the endoscopists will receive a course on endoscopic polypectomy and the other their rate of complete resection. The number of polyps required will vary depending on the number of endoscopists The primary objective will be compared using logistic regression models based on generalized estimating equations (GEE), taking into account the within-subject correlation.

NCT ID: NCT04516785 Completed - Colorectal Cancer Clinical Trials

Reducing Colonoscopies in Patients Without Significant Bowel Disease

RECEDE
Start date: September 17, 2020
Phase:
Study type: Observational

Investigating people with bowel symptoms uses a test that detects traces of blood in the stools, the FIT test. There are many possible reasons for positive tests. A few people have cancer. However, most participants with symptoms don't have any serious bowel disease but have benign problems such as piles or irritable bowel syndrome (IBS). It is very difficult to diagnose on symptoms alone, those participants who have serious bowel disease and those who do not. After a positive test, people are invited for colonoscopy - a sort of articulated tube that is passed up the bowel. Most people invited for colonoscopy don't have cancer. Only about 5% of those with positive FIT tests have cancer. About 25% have other bowel diseases, but most have nothing serious wrong at all. So they have the inconvenience and discomfort of colonoscopy but don't get any benefit from it. The investigators want to try adding another test, the volatile organic compound (VOC) test, to see if the investigators can separate those with positive FIT tests who do have something wrong, from those who don't. The VOC test uses a urine sample. Using both tests might also be better for detecting cancer. FIT alone misses about 20%. So the investigators think that using both tests might not only be better for detecting cancer, but also might mean that a lot of people will avoid having to have colonoscopy. This study will recruit 1,819 participants with bowel symptoms from NHS trusts in the UK. They will provide stool samples for FIT and urine for VOC analysis. They will have colonoscopy to get a definite diagnosis. Then the investigators will look at their FIT and VOC test results to see if in future, people with both tests negative.

NCT ID: NCT04490551 Completed - Colorectal Cancer Clinical Trials

Combining Risk Factors and Faecal Immunochemical Testing in Colorectal Cancer Screening: a Randomized Controlled Trial

Start date: December 5, 2019
Phase: N/A
Study type: Interventional

Colorectal Carcinoma (CRC) is the third most frequent diagnosed cancer worldwide, with 1.4 million new cases every year. In an attempt to reduce this number many countries have implemented a nationwide screening programme targeted at detecting CRC in an early phase using fecal immunochemical tests (FITs). People with an elevated level of blood in their stool are offered a colonoscopy, an invasive medical procedure where CRCs and premalignant lesions (together also referred to as advanced neoplasia) can be detected accurately. However, the current screening method using FIT is not optimal. In FIT-based CRC screening studies, 1 in 4 participants with CRC and 2 in 3 participants with advanced neoplasia receive a negative FIT result. In contrast, an estimated 1 in 2 FIT-positives have advanced neoplasia at colonoscopy. Recent studies have demonstrated that a risk model that takes into account the FIT result and other risk factors for CRC could enhance the effectiveness of a FIT-based CRC screening programme. The objective of this study is to assess the yield of advanced neoplasia in the colon and rectum of a FIT-based risk model at colonoscopy, compared to that of a FIT-only CRC screening strategy. Our hypothesis is that a risk-based model yields significantly more advanced neoplasia at colonoscopy than the FIT by itself, and that it does not affect participation rate. To assess this hypothesis, the investigators have designed a clinical trial in which the investigators randomize 23,000 asymptomatic individuals between the age of 55 and 75 years old to either risk-based screening (intervention group) or FIT-only screening (control group). The intervention group will receive a questionnaire on risk factors of CRC (e.g. smoking, family history of CRC), and a FIT. The control group will only receive the FIT. The positivity threshold of the FIT in both groups will be set at 15 micrograms haemoglobin per gram faeces. The positivity threshold of the risk-based model in the intervention group will be set at 0.10 (out of a range of 0 to 1), a threshold that is calculated with a goal to match the positivity rate of the control group. Participants with a result that is above the thresholds of the FIT and/or the risk-based model will be invited to undergo a colonoscopy according protocol of the Dutch national screening program. After the study has ended, the investigators will compare both groups to assess our hypotheses.

NCT ID: NCT04473677 Completed - Colorectal Cancer Clinical Trials

A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma

Start date: August 17, 2020
Phase:
Study type: Observational

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, the sensitivity of existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared with existing commercially available qFIT, is developed and this study will prove the high diagnostic accuracy in detecting colorectal advanced adenoma.

NCT ID: NCT04464837 Not yet recruiting - Colorectal Adenoma Clinical Trials

Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm

COLDSNAP-1
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen. In this feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.

NCT ID: NCT04444908 Recruiting - Colorectal Adenoma Clinical Trials

Development and Validation of an Artificial Intelligence-assisted Strategy Selection System for Colonoscopy Cleaning

Start date: May 11, 2020
Phase:
Study type: Observational

Patients with poor inadequate bowel preparation need to undergo secondary colonoscopy. but the evaluation of intestinal cleanliness is judged by doctors subjectively. there are no objective and effective criteria to guide the evaluation. We use the deep learning technique to develop the EndoAngel with real-time intestinal cleanliness assessment. It can derive a decision curve for bowel cleanliness based on the relationship between the percentage of bowel segments with a Boston score of 1 and the adenoma detection rate. It can help doctors to identify patients who need a second colonoscopy, and provide a new way for artificial intelligence in improving the detection rate of colonoscopic adenomas.

NCT ID: NCT04216251 Completed - Colorectal Cancer Clinical Trials

PRevention Using EPA Against coloREctal Cancer

PREPARE
Start date: December 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. - The name of the study drug involved in this study is: -- AMR101 (VASCEPA).