23 Clinical Trials for Various Conditions
This study is a prospective, single-arm, multi-center, open-label, staged clinical study. Overall Objective: 1. To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge). 2. To validate a program for training surgeons and their teams to successfully use the ELS System.
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.
This randomized phase II trial is studying how well erlotinib hydrochloride works in treating patients with stage I-III colorectal cancer or adenoma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Erlotinib hydrochloride may also stop tumors from growing or coming back
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors. PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma (cancer) of unknown primary origin.
The primary objective is to determine the sensitivity and specificity of the Exact Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination. The secondary objective is to compare the performance of the Exact CRC screening test to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis. PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps. PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps \<=3mm during colonoscopy.
The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.
The purpose of this study is to examine the role of an automatic polyp detection software (henceforth referred to as the research software) as a support system during colonoscopy; a procedure during which a physician uses a colonoscope or scope, to look inside a patient's rectum and colon. The scope is a flexible tube with a camera-to see the lining of the colon. The research software is used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. The research software used in this study was programmed by a company in Shanghai, which develops artificial intelligence software for computer aided diagnostics. The research software was developed using a large repository (database or databases) of polyp images where expert colonoscopists outlined polyps and suspicious lesions. The software was subsequently developed and validated using several databases of images and video to operate in near real-time or within minutes of photographing the tissue. It is intended to point out polyps and suspicious lesions on a separate screen that stands behind the primary monitor during colonoscopy. It is not expected to change the colonoscopy procedure in any way, and the physician will make the final determination on whether or not to biopsy or remove any lesion in the colon wall. The research software will not record any video data during the colonoscopy procedure. In the future, this software may help gastroenterologists detect precancerous areas and decrease the incidence of colon cancer in the United States.
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.
The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.
The iCaRe2 is a multi-institutional resource created and maintained by the Fred \& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.
RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer, patients with colorectal polyps and from patients without polyps may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at biomarkers in blood and tissue samples from patients with colorectal cancer or colorectal polyps and from patients without polyps (healthy volunteers).
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps. PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.
RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment. PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.
RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer. PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.