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600 active trials for Colorectal Cancer

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

This study is a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Start: July 2019

Gut Microbiome Modification Through Dietary Intervention in Patients With Colorectal Cancer: Response to Surgery

The investigators will conduct an open, controlled, randomized clinical trial, in patients with scheduled surgical intervention for CRC in the General Surgery and Digestive System Unit of the Virgen de la Arrixaca University Hospital (Murcia, Spain). All the included individuals must have passed the protocol of the Virgen de la Arrixaca University Hospital to be candidates for elective major surgery for CRC and must sign the informed consent after being informed of the objectives and the methodology of the study. The Helsinki Declaration will be followed during the duration of the project. Patients will be randomized in a 1:1 ratio after receiving a diagnosis of CRC in the endoscopic evaluation; in the control arm, patients will receive standard nutritional recommendations, while patients in the intervention arm will be advised to follow a high-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery

Start: May 2021

Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy

This is a phase I clinical trial assessing the safety and recommended phase II dose of cabozantinib in combination with trifluridine/tipiracil (TAS102) in patients with metastatic colorectal carcinoma (mCRC).

Start: July 2021

Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System

Nearly 70% of people living with cancer are "complex patients" with multiple chronic conditions who must deal not only with effects of their cancer but also continuing diseases such as diabetes, depression, hypertension, or heart disease. Care coordination strategies shown to be effective in improving outcomes for common medical conditions seen in primary care include: systematic transitions for patients to and from specialty care; intensive case management; and a team-based approach to comprehensive care. Despite an Institute of Medicine report suggesting these strategies as potential ways to improve care for cancer survivors, their implementation has not yet been evaluated for cancer survivors. Parkland Health and Hospital Systems will be implementing care coordinator strategies as part of as quality assurance/quality improvement activities, which Aim 2 and Aim 3 (research components) will evaluate. This protocol has been organized to reflect this distinction between the aims. The investigators expect no more than 1500 patients to be included in these study aims.

Start: September 2017

Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.

Start: June 2021

Tumoral Circulating Cells and Colorectal Cancer Progression

Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

Start: July 2017

Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.

Start: April 2017

Prevention of Colorectal Cancer Through Multiomics Blood Testing

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.

Start: May 2020

Safety and Feasibility of ActivSightTM in Human

ActivSightTM combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. Primary Objective: To determine safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

Start: November 2020

Comparing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis

The purpose of this trial is to compare the morbidity and mortality of CRS-HIPEC using mitomycin-C versus melphalan for colorectal peritoneal carcinomatosis. Morbidity and mortality will measured using the Comprehensive Complication Index (CCI) score, Common terminology criteria for adverse events (CTCAE version 4.03), and the Clavien-Dindo Classification.

Start: July 2017

Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study

Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. Recently, several of these risk factors were implemented in the updated British guidelines for surveillance which are now used to determine surveillance intervals in our center. The new guideline recommends stratification of patients in a high, medium or low risk group depending on the presence of clinical and endoscopic risk factors and to adjust the surveillance interval accordingly. Although these guidelines provide a first step towards an individualized surveillance regimen, current data regarding risk factors for IBD-associated CRC are solely based on retrospective studies. Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed to further optimize surveillance in the future. Objectives: To confirm established and identify new predictive factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome. To provide evidence that mucosal healing results in a significant reduction of colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA or anti-TNF maintenance therapy. Study the expression of several tumor markers in biopsies, blood and faeces at baseline and determine whether expression of these markers can predict dysplasia or colorectal cancer development during follow-up.

Start: July 2011

Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)

This is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl esters capsules (generic Lovaza) on molecular, and intestinal microbiota changes in participants at high risk for colorectal cancer. The study will be a single arm, open label study.

Start: February 2019

Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia

This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.

Start: August 2020

Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

This study will evaluate the safety and efficacy of VE800 in combination with Nivolumab in patients with selected types of advanced or metastatic cancer

Start: January 2020

Cancer Surveillance and Support

This project aims to enhance the support for patients with breast and bowel cancer after treatment. Current follow-up care includes either self-management with patient-initiated contacts (breast cancer) or scheduled hospital visits for scans/tests for recurrence (bowel cancer). Building on extensive experience with online patient self-reporting of symptoms during treatment, the study will develop, implement and evaluate satisfaction with an improved electronic system to engage breast and bowel cancer survivors to self-report symptoms/problems online from home and get immediate tailored advice for self-management or hospital contact. The reports are displayed real-time in the hospital records alongside scans/tests to inform clinical management.

Start: March 2021

DNA Adductomics for Colorectal Cancer Investigation

This project seeks to identify DNA-adducts in colon tissue from different groups of patients with CRC scheduled for complete or partial colon resections. Other patients scheduled for resection of the colon serve as controls. In addition, surrogate samples such as white blood cells are investigated for the presense of adducts while blood plasma and urine are investigated for the presense of DNA-repair products.

Start: February 2021

A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer

This study will evaluate the safety, tolerability, and pharmacokinetics of BLYG8824A and will make a preliminary assessment of the anti-tumor activity of BLYG8824A in patients with locally advanced or metastatic colorectal cancer.

Start: August 2020

Integration of Cancer Health Activities Into African American Churches

The proposed project will compare two ways to apply a known-effective cancer educational strategy through African American churches: 1) a standard method vs. 2) a new method in which the churches integrate the strategy into their organizational structure and practice at multiple levels. It will be determined whether this "integrated approach" results in more effective and sustained cancer education and screening activities at both the church and individual levels over time. This project will make important contributions to research in evidence-based medicine and sustainability. In a climate of limited resources, identifying sustainable and effective ways to increase cancer awareness and screening in African American men and women is more important than ever.

Start: July 2016

Protein Needs in Cancer

Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health. However, current nutritional recommendations are not specific or evidence-based. The aim of this project is to determine the protein needs of patients with colorectal cancer. Protein needs will be determined using a novel, non-invasive approach. Our results will inform nutritional recommendations and guidelines with the ultimate goal of improving outcomes for people with cancer.

Start: April 2021

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

Start: June 2016