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Colorectal Neoplasms clinical trials

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NCT ID: NCT04153721 Completed - Colorectal Cancer Clinical Trials

Impact Study of a Digital Solution for Patient Engagement

Get Ready
Start date: March 11, 2020
Phase: N/A
Study type: Interventional

The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative). Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes. Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital. The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices. The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device. This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.

NCT ID: NCT04144751 Completed - Colorectal Cancer Clinical Trials

Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"

Start date: November 15, 2019
Phase:
Study type: Observational

The primary objective of this sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).

NCT ID: NCT04144738 Completed - Colorectal Cancer Clinical Trials

Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Start date: November 15, 2019
Phase:
Study type: Observational

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

NCT ID: NCT04131946 Completed - Clinical trials for Colorectal Cancer Screening

Cancer Screening; Access; Awareness; Navigation

Start date: November 12, 2019
Phase: N/A
Study type: Interventional

To assess the feasibility and efficacy of community-based Colorectal Cancer (CRC) screening intervention in increasing CRC screening rates To evaluate individual-level knowledge related to CRC screening and risk factors To characterize individual -level facilitators and barriers to engaging in CRC screening and related diagnostic tests and treatment when applicable.

NCT ID: NCT04129177 Completed - Clinical trials for Colorectal Neoplasms

Reduction of Surgical Site Infections in Elective Colorectal Surgery After the Implementation of a Bundle of Care.

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

Background. The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors SSI in elective colorectal surgery since 2007 in 56 hospitals (7.5 million population). These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015, the SSI rate did not change significantly, with a cumulated incidence of 5,491 SSI in a total of 29,006 interventions (19%). In 2015, a working group of VINCat specialists and surgeons from the Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative measures for colorectal surgery. Aim. To analyse the effect of a specific bundle for SSI prevention in elective colorectal surgery. Methods. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor. The results of SSI before and after the implementation of the bundle are compared. The results are analysed using the chi-square test (statistical significance p <0.05).

NCT ID: NCT04126733 Completed - Colorectal Cancer Clinical Trials

Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)

Start date: October 14, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for patients. Regorafenib works by blocking several different proteins involved in tumor growth. Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells. Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.

NCT ID: NCT04080843 Completed - Colorectal Cancer Clinical Trials

Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients

ALTER-C-002
Start date: November 15, 2019
Phase: Phase 2
Study type: Interventional

This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with mCRC. The patients who are pathologically confirmed as RAS and BRAF wild-type mCRC will be enrolled. Condition or disease Invention/treatment Phase Colorectal Cancer Drug: Anlotinib Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2

NCT ID: NCT04080414 Completed - Colorectal Cancer Clinical Trials

Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence

Start date: August 2, 2019
Phase: N/A
Study type: Interventional

This 12-week, exercise study will assess the feasibility of a home-based high-intensity interval training (HIIT) program among colorectal cancer survivors and explore the impact of home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic exercise program on physical outcomes linked with survival from colorectal cancer and surrogate blood markers of colorectal cancer recurrence. HIIT is a type of aerobic exercise that includes short bursts (i.e. 1-4 minutes) of vigorous exercise followed by longer periods of moderate to lower intensity exercise (i.e. 1-10 minutes). Participants in this study will be randomly assigned into a personalized home based exercise program - either high-intensity interval training (HIIT) or moderate-intensity continuous aerobic exercise (MICE). This pilot study will provide us with preliminary evidence for a larger trial aimed to compare the effectiveness of these two different types of home-based exercise programs on physical outcomes linked with survival, quality of life, and surrogate blood markers of colorectal cancer recurrence.

NCT ID: NCT04069702 Completed - Colorectal Cancer Clinical Trials

Virtual Reality for Improving Pain and Distress in Patients With Advanced Stage Colorectal Cancer

VR Blue
Start date: March 12, 2020
Phase: N/A
Study type: Interventional

Patients with advanced colorectal cancer often experience high levels of debilitating pain and pain-related psychological distress. Pain in cancer patients is typically treated with analgesics. There is growing agreement that non-pharmacological pain management strategies are needed to treat pain in advanced cancer patients. Recent evidence suggests Virtual Reality (VR) experiences can lead to reductions in acute pain; however, VR has not been tested in advanced cancer patients having persistent pain. VR could represent a valuable addition to our current armamentarium of treatments for persistent pain in palliative care patients. VR provides individuals with an immersive computer-generated environment that can reduce pain, tension and distress. The proposed study builds upon and extends preliminary research in healthy participants conducted by Luana Colloca, MD, PhD. Dr. Colloca is a consultant on this project and the proposed study would be the first to extend VR Blue to a clinical population and test its effects on clinical pain. The objective is to gather initial data on advanced colorectal cancer patients' immediate response to a single VR session. The investigators will examine feasibility, acceptability, safety, and impact of exposure to VR Blue on the clinical pain experience of advanced colorectal cancer patients. The study will collect data on pain, tension and distress pre-, midpoint, and post-VR. The investigators will also examine how pre- to post-VR changes in key cognitive variables (i.e., pain catastrophizing, pain self-efficacy) relate to VR-related changes in pain, tension and distress. The investigators will also collect qualitative data following participants' VR experience to better understand patients' preferences, thoughts and feelings about the VR experience. Data will be used to optimize VR Blue for future study, including developing an intervention to support a multi-session VR protocol for advanced colorectal cancer patients. The proposed study represents the first step in a program of clinical research that seeks to test the efficacy of VR in improving pain and pain-related symptoms in advanced colorectal cancer patients. In the proposed study, the investigators will collect quantitative and qualitative data on the impact of VR Blue on pain and pain-related outcomes in 20 advanced colorectal cancer patients.

NCT ID: NCT04067960 Completed - Clinical trials for Malignant Solid Neoplasm

Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer

Start date: June 6, 2019
Phase: Early Phase 1
Study type: Interventional

This early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.