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Colorectal Adenocarcinoma clinical trials

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NCT ID: NCT06271980 Completed - Colorectal Cancer Clinical Trials

Early-Onset Colorectal Cancer Recurrence

ENCORE
Start date: April 15, 2023
Phase:
Study type: Observational

Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance. This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid)

NCT ID: NCT05592873 Completed - Clinical trials for Colorectal Adenocarcinoma

Oncological Impact of Lateral Nodes in Rectal Cancer

I-ONARC
Start date: January 1, 2014
Phase:
Study type: Observational

The combination of neoadjuvant chemoradiotherapy (CRT) and total mesorectal excision (TME) is considered the standard treatment for locally advanced rectal cancer in the western world. Appropriate preoperative treatment and margin free surgery are key-elements in reducing the local-recurrence of the tumor and consequently improving overall survival. Nevertheless, the local recurrence of stage II and III rectal cancer is still high, with current levels of 5% to 10% even when R0 resection is achieved. Most of the cases of loco-regional recurrence are associated with lateral lymph nodes (LLN) spread of cancer cells, which is not always controlled by the preoperative chemotherapy. As a matter of fact, the incidence of LLD metastases has been estimated to range from 11% to 22% in patients with T3/4 rectal cancer below the peritoneal reflection. In order to improve these poor outcomes, Japanese surgeons have adopted extended lymphadenectomy with the dissection of lateral extramesorectal lymph nodes as the standard of care for T2-3 low rectal cancer patients5. While this approach is widely used in Japan and Korea, western surgeons have preferred a less aggressive approach, indicating lateral lymph node dissection (LLND) only in presence of clinically highly suspicious lateral pelvic lymph nodes on baseline magnetic resonance imaging (MRI). Thus, it is essential to identify preoperative predictive factors of LLN metastasis. Even if MRI is considered the optimal diagnostic tool in rectal cancer, its accuracy for LLN staging is considered poor, especially after neoadjuvant treatment. LLNs often change in both features and size after CRT, and this behaviour might not be in concordance with the response of the primary tumor. To the best of our knowledge, no consensus exists on whether the risk of local recurrence should be determined by assessing the features of LLN on the primary MRI or on the restaging MRI. Moreover, the relation between LLN response and primary tumor regression grade after neoadjuvant CRT needs to be thoroughly explored. This multicenter cohort study aimed to investigate factors on primary and restaging MRI associated with lateral nodal recurrence and to identify patients who may benefit from LLND after neoadjuvant treatment for locally advanced rectal cancer.

NCT ID: NCT05477836 Completed - Colorectal Cancer Clinical Trials

Feasibility and Safety of MiWEndo-assisted Colonoscopy

MiWEndo1
Start date: October 18, 2022
Phase: N/A
Study type: Interventional

The study involves the planned use of a new microwave-based device during colonoscopy procedures in a small group of patients to assess the preliminary safety of its use and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies, including: phantom studies, an ex vivo study with human tissues, and an in vivo study with animal model (pig).

NCT ID: NCT04898842 Completed - Colorectal Cancer Clinical Trials

Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet

BOUNCED
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

Bowel obstruction is a common complication in patients with ovarian, peritoneal and bowel cancer due to a mass or spread of disease, causing narrowing to the gut, as these cancers can grow on the bowel surface. Certain foods may lead to symptoms such as pain, bloating, feeling full, feeling sick, vomiting and difficulty passing a bowel motion. There is limited evidence to establish the best diet to follow when someone is diagnosed with the risk of bowel obstruction and is experiencing symptoms after eating and drinking. The Dietitians at the Royal Surrey have developed a 4 stage bowel obstruction diet which they have been using with patients for 3 years. The 4 stages are clear fluids, all thin liquids, low fibre soft smooth diet, low fibre soft sloppy diet. Depending on the severity of symptoms and the risk of a blockage, patients are asked to follow a certain stage of the diet. They are advised to move up and down the stages as symptoms improve or get worse. This feasibility study aims to investigate if the diet can be used and is effective in clinical practice. The objectives are to see if this diet is easy to follow, can reduce symptoms of bowel obstruction, can improve quality of life, and reduce admissions to hospital because of bowel blockages. Patients at risk of bowel obstruction from colorectal or ovarian cancer are eligible to participate. They will remain in the study for a period of 4 weeks, during which time they will be asked to complete a diet diary and 3 questionnaires.

NCT ID: NCT03958500 Completed - Colorectal Cancer Clinical Trials

The Problem of Colorectal Anastomosis Safety

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

This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.

NCT ID: NCT03706235 Completed - Clinical trials for Colorectal Adenocarcinoma

Colvera for Detection of Disease Recurrence

NOVA
Start date: February 1, 2018
Phase:
Study type: Observational

To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in CRC subjects who are undergoing surveillance for recurrence.

NCT ID: NCT03683446 Completed - Colorectal Surgery Clinical Trials

Trends and Outcomes in Laparoscopic Versus Open Surgery for Rectal Cancer

NSQIPc
Start date: January 1, 2005
Phase:
Study type: Observational [Patient Registry]

Retrospective cohort study used to analyze trends in minimally invasive versus open surgery in colorectal surgery, over time, in outcome in the laparoscopic, robotic and open surgery groups in patients receiving colorectal resections. Analysis will be performed using data collected through the American College of Surgeons (ACS) National Surgical Quality Improvement Project (NSQIP) database, a national database with deidentified data entered by trained nurse data reviewers.

NCT ID: NCT03373188 Completed - Clinical trials for Pancreatic Adenocarcinoma

VX15/2503 and Immunotherapy in Resectable Pancreatic and Colorectal Cancer

Start date: December 15, 2017
Phase: Phase 1
Study type: Interventional

This randomized phase I trial studies how well anti-semaphorin 4D (anti-SEMA4D) monoclonal antibody VX15/2503 with or without ipilimumab or nivolumab work in treating patients with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer that has spread to the liver and can be removed by surgery. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03367611 Completed - Colorectal Cancer Clinical Trials

Use of iFOBT in Patients Presenting With Alarm Symptoms of Colorectal Cancer

Start date: March 15, 2018
Phase: N/A
Study type: Interventional

Background: Colorectal cancer (CRC) is one of the most common types of cancer in Denmark, and mortality among patients is high. Patients presenting with alarm symptoms of CRC are referred to colonoscopy in the cancer patient pathway for CRC. However, the proportion of patients with alarm symptoms who have CRC is below 10%. Simultaneously, the burden on endoscopy units to conduct fast-track colonoscopies is growing. Occult blood in the faeces may be an early sign of cancer or precancerous lesions, and can be detected by an immunochemical faecal occult blood test (iFOBT). Few studies have examined the diagnostic properties of the iFOBT among symptomatic patients, and reported sensitivities ranging from 88%-100%, specificities from 77%-94%, and negative predictive values from 98%-100%. These results were derived from diverse patient populations, and used different cut-offs to define positive test results. Using iFOBT may be a valuable tool for the GP when deciding on referral of the patient to the cancer patient pathway. However, evidence is needed on the diagnostic accuracy of the test to detect CRC among patients presenting with alarm symptoms. Hypothesis: In patients presenting with alarm symptoms of CRC, detection of faecal occult blood by iFOBT is an accurate measure of the presence of colonic lesions. Aim: The aim of the study is to examine the diagnostic accuracy of the iFOBT among symptomatic patients referred to colonoscopy in the cancer patient pathway for CRC. Materials and methods: The project is conducted as a diagnostic accuracy study. Patients appointed for colonoscopy will be invited to collect a faecal sample and mail it for analysis. The iFOBT result will be registered in a computer-based laboratory information system. The result of the colonoscopy will be registered in Danish national health registries. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated as measures of the diagnostic properties of the iFOBT, using the result of colonoscopy as the reference standard. The accuracy of the test by type of alarm symptom will also be assessed. Perspectives: The study will provide new and valuable data to evaluate the referral criteria for the cancer patient pathway. Given a good discriminatory ability of the iFOBT among symptomatic patients, fast-track colonoscopy may not be necessary as a first-choice examination in the diagnostic work-up of these patients.

NCT ID: NCT03206073 Completed - Colorectal Cancer Clinical Trials

A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer

Start date: December 7, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Immune-based approaches in colorectal cancer have unfortunately with the notable exception of immune checkpoint inhibition in microsatellite instable (MSI-hi) disease been largely unsuccessful. The reasons for this are unclear but no doubt relate to the fact that in advanced disease colorectal cancer appears to be less immunogenic, as evidenced by the lack of infiltrating lymphocytes with advancing T stage - Pexa-Vec (JX-594) is a thymidine kinase gene-inactivated oncolytic vaccinia virus engineered for the expression of transgenes encoding human granulocyte- macrophage colony-stimulating factor (GM-CSF) and beta-galactosidase. Apart from the direct oncolytic activity, oncolytic viruses such as Pexa-Vec have been shown to mediate tumor cell death via the induction of innate and adaptive immune responses - Tremelimumab is a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) expressed on the surface of activated T lymphocytes and causes inhibition of B7-CTLA-4-mediated downregulation of T-cell activation. Durvalumab is a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1). - The aim of the study is to evaluate whether the anti-tumor immunity induced by Pexa-Vec oncolytic viral therapy can be enhanced by immune checkpoint inhibition. Objective: -To determine the safety, tolerability and feasibility of Pexa-Vec oncolytic virus in combination with immune checkpoint inhibition in patients with refractory metastatic colorectal cancer. Eligibility: - Histologically confirmed metastatic colorectal cancer. - Patients must have progressed on, been intolerant of or refused prior oxaliplatin- and irinotecan-containing, fluorouracil-based, chemotherapeutic regimen and have disease that is not amenable to potentially curative resection. Patients who have a known Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type tumor must have progressed, been intolerant of or refused cetuximab or panitumumab based chemotherapy. - Patients tumors must be documented to be microsatellite-stable (MSS) either by genetic analysis or immunohistochemistry OR microsatellite-high with documented disease progression following anti-programmed cell death protein 1 (PD1)/Programmed death-ligand 1 (PDL1) therapy. - Patients must have at least one focus of metastatic disease that is amenable to pre- and on-treatment biopsy. - Willingness to undergo mandatory tumor biopsy. Design: -The proposed study is Phase I/II study of Pexa-Vec oncolytic virus at two dose levels in combination with immune checkpoint inhibition in patients with metastatic colorectal cancer.