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Colorectal Cancer clinical trials

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NCT ID: NCT06212817 Recruiting - Colorectal Cancer Clinical Trials

Dietary Fiber Before Colorectal Cancer Surgery

Start date: April 29, 2024
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to investigate the feasibility of increasing preoperative dietary fiber intake in individuals with colorectal cancer who will undergo surgery. This will be done using 1) digital personalized dietary advice or 2) a dried vegetable product compared to 3) habitual diet (control).

NCT ID: NCT06212700 Recruiting - Colorectal Cancer Clinical Trials

PRIORITY-CONNECT 2 Pilot Trial

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications. Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care. The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.

NCT ID: NCT06210724 Recruiting - Colorectal Cancer Clinical Trials

FIT in Diverticulitis

Start date: October 9, 2023
Phase:
Study type: Observational

Background and study aims Diverticular disease or diverticulosis is a benign disease of the colon. Anatomically this is formation of pockets of bowel wall which protrude through weaknesses in the muscular wall of the colon. The mechanisms leading to their formation remains unclear and is likely a complex interaction of multiple factors. For the majority of people these pockets are incidental findings but for some they can cause symptoms or a segment of colon containing them can become inflamed which is called acute diverticulitis. The main aim of this study is to see if a faecal samples, which will be tested for hidden blood content with a faecal immunochemical test for haemoglobin (FIT), could be used as an alternative to currently used follow-up investigations for patients who have an episode of acute diverticulitis confirmed on a computerised tomography (CT) scan. These are colonoscopy, sigmoidoscopy or a special CT called CT colonoscopy. We will also be doing a test called faecal calprotectin which is a marker of bowel inflammation and an assessment of the microbes that live in the bowel to see if this will provide further insights into the diagnosis and treatment of diverticulitis. Who can participate? All patients 18 or over admitted to a participating hospital with acute diverticulitis confirmed on a CT scan and who planned to have one of the currently used follow-up investigations are eligible. What does the study involve? The study will involve taking three stool (faecal) samples using faecal testing kits posted to participants. One is on their first solid stool after diagnosis (or as early as possible if their first solid stool is before receiving this pack), the others are at 3 weeks after diagnosis and then 6 weeks after diagnosis. What are the possible benefits and risks of participating? There are no risks of participating. FIT testing has been used in cancer screening now for a number of years and we hope to demonstrate that a negative FIT test for patients after acute diverticulitis will be able to exclude a bowel cancer and prevent the majority of future patients having invasive and time consuming tests. There no additional benefit for participants for their current episode, as they will still need to have these tests. Where is the study run from? Royal Surrey County Hospital When is the study starting and how long is it expected to run for? 09/10/2023-30/09/2024 Who is funding the study? The study is being funded by MATTU (Minimal Access Therapy Training Unit), GUTS (GUTS - Fighting Bowel Cancer) and NHIR (National Institute for Health and Care Research). Who is the main contact? James Norman On the study email rsch.colorectalDfitstudy@nhs.net

NCT ID: NCT06206603 Recruiting - Colorectal Cancer Clinical Trials

Epigenetic Regulation of Colorectal Polyps and Cancer

Start date: January 3, 2024
Phase:
Study type: Observational

The goal of this study is to learn about the epigenetic and genetic regulation (microRNA/mRNA) of colorectal polyps and their evolvement as polyps and to colorectal cancer. Furthermore, the study aims at investigating whether certain epigenetic features, linked to polyps and/or cancer are traceable in blood samples. The main questions the study aims to answer are: 1. Are there specific microRNA/mRNA that are expressed in different types of polyps and cancers and their respective stages? 2. Is microRNA/mRNA expression in polyps and cancer traceable in blood from the same patient? 3. Is the intestinal microbiata correlated with colorectal polyps and cancer and their microRNA/mRNA expression? Type of study: clinical trial Participant population Participants consist of patients undergoing a scheduled colonoscopy where a polyp or cancer is discovered. Healthy controls, with normal colonoscopy findings will be enrolled. Biopsies will be obtained from polyps/cancers and from normal surrounding intestinal mucosa. Biopsies will be obtained from defined intestinal locations from healthy controls. Blood samples will be collected from all participants. Researchers will compare microRNA/mRNA and microbiota in patients with polyps/cancers and their respective stages as well as healthy controls. Comparisons include biopsies and blood samples.

NCT ID: NCT06206096 Recruiting - Colorectal Cancer Clinical Trials

PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for RAS-mut MSS mCRC

Start date: May 26, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to explore the efficacy and safety of anti-PD-1 antibody plus bevacizumab and chemotherapy as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer.

NCT ID: NCT06205836 Recruiting - Colorectal Cancer Clinical Trials

Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater.

NCT ID: NCT06204484 Recruiting - Colorectal Cancer Clinical Trials

MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer

MIRROR
Start date: July 26, 2023
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to test whether minimal residual disease (MRD) status detected by circulating tumor DNA (ctDNA) could be used to guide precision therapy of post-surgery in colon cancer. The colon cancers are intended for resectable colon cancer of high-risk stage II and low-risk stage III status. The main questions it aims to answer are: 1. Whether patients with MRD negative status could benefit from deferred adjuvant therapy. 2. Whether patients with MRD positive status need intensive adjuvant therapy. The qualified participants will go through two different randomized groups according to the post-surgery 1-month MRD status. In MRD negative groups, participants will be divided into standard adjuvant therapy groups and deferred adjuvant therapy groups at 1:2 ratios. In MRD positive groups, participants will be divided into standard adjuvant therapy groups and intensive adjuvant therapy groups at 1:2 ratios. All the patients will receive MRD detection every 3 months and radiological evaluation every 6 months up to 3 years, and survival follow-up up to 5 years.

NCT ID: NCT06200831 Recruiting - Colorectal Cancer Clinical Trials

Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases

SYLMET
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

NCT ID: NCT06194877 Recruiting - Colorectal Cancer Clinical Trials

A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers

Start date: April 18, 2024
Phase: Phase 1
Study type: Interventional

The primary objectives of Part 1 of this study are to: - Assess the safety and tolerability of the combination of BGB-3245 and panitumumab in participants with advanced or metastatic colorectal cancer (CRC) with a known mutation status and tumor harboring an oncogenic mutation of v-Raf murine sarcoma viral oncogene homolog B; B-RAF proto-oncogene, serine/threonine kinase (BRAF), Kirsten rat sarcoma viral oncogene homolog (KRAS), or neuroblastoma RAS viral oncogene homolog (NRAS) with documented disease progression during or after at least 1 line of prior therapy. - Determine the maximum tolerated dose (MTD) of BGB-3245 in combination with panitumumab and the recommended phase 2 dose (RP2D) of the combination. The primary objective of Part 2 of this study is to determine the objective response rate (ORR) as assessed by initial investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with BGB-3245 and panitumumab combination treatment at the RP2D.

NCT ID: NCT06184867 Recruiting - Breast Cancer Clinical Trials

Choices About Genetic Testing And Learning Your Risk With Smart Technology

CATALYST
Start date: October 26, 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among cancer survivors. The study objectives are to: 1. Finalize the development and optimize usability of the CATALYST digital intervention (i.e., also known as relational assistant (RA)) 2. Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model in cancer survivors. Participants will be randomized to one of two study arms: the RA intervention vs. enhanced usual care (EUC) 3. Assess GC and GT uptake and conduct a process evaluation to measure barriers/facilitators to GC, GT and use of the CATALYST intervention and engagement with the RA.