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Colon Cancer clinical trials

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NCT ID: NCT01378013 Completed - Breast Cancer Clinical Trials

SurgicAl Metabolic Phenotyping Longitudinal Evaluation Study

SaMPLE
Start date: August 2011
Phase: N/A
Study type: Observational

This work will use a new approach to measure how surgery effects human biochemistry and metabolism. It will create a metabolic signature or 'phenotype' for surgical injury that will help clinicians choose the right surgical treatments for an individual. This is because metabolism is based on an individual's genes, disease burden and environmental influences such as gut microbiota. This study will use a scientific method based on computational analysis of spectra taken from techniques known as Mass Spectrometry (MS) and Nuclear Magnetic Resonance (NMR) spectroscopy. This science is called 'metabonomics' and it has many advantages. Firstly, it provides a measure of thousands of metabolites at a single moment in time that are unique to the individual and it therefore gives a 'systems' overview of a persons metabolism. Secondly it is able to process many hundreds of samples quickly. The investigators are aiming to integrate the investigators metabolic data with genetic information about patients or bacteria wherever possible. This will be the first time that a 'systems biology' approach has been used in surgery, with potentially significant gains to me made in pre operative risk stratification and optimisation. By performing this analysis at all stages of the surgical journey (preoperatively, during the operation and after the surgery) it will ensure the right treatments are given to the right patient at the right time. By creating longitudinal models of the biochemical responses to surgery, predict at a much earlier stage those patients at risk of developing complications. This will improve outcome after surgery. This work will use a metabonomic approach to create new tools for surgeons to use during operations based on tissue biology. For example the investigators will be able to measure the metabolic content of tumours in real time by measuring the biological content of diathermy smoke. This has the potential to change intra-operative decision making and further improve outcome.

NCT ID: NCT01372553 Completed - Breast Cancer Clinical Trials

Guilford Genomic Medicine Initiative (GGMI)

GGMI
Start date: October 2009
Phase: Phase 4
Study type: Observational

- Genomic medicine, using genetic information to improve health outcomes, is heralded as the answer to rising medical costs by focusing on prevention and tailored care. Despite its potential, little investigation has focused on how genomic medicine can be applied in health care. To be effective, it requires new ways to learn, deliver, and communicate medical information. It will also raise new ethical questions. - The overall goal of Guilford Genomic Medicine Initiative (GGMI) is to identify the specific challenges in "re-structuring" an existing medical system to integrate genomic medicine, and create solutions that can be used by other medical systems, such as the extensive military medical care system. To accomplish this goal, GGMI includes the development of a large-scale genomic medicine education initiative targeted at the community, providers, and patients, and a clinical systems model to implement strategies to facilitate the integration of genomic medicine into several pilot practices.

NCT ID: NCT01363843 Completed - Rectal Cancer Clinical Trials

Complete Neoadjuvant Treatment for REctal Cancer (CONTRE)

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out how well patients with cancer of the rectum do if they get all of their other treatment - chemotherapy by itself followed by chemotherapy and radiation together - before surgery. Patients have recently been diagnosed with rectal cancer, and the doctors have recommended neo-adjuvant chemo treatment to try to shrink the cancer before removing it.

NCT ID: NCT01351220 Completed - Rectal Cancer Clinical Trials

Community Dissemination of an Evidence-based Colorectal Cancer (CRC) Screening Intervention

Start date: July 2010
Phase: N/A
Study type: Interventional

Filipino Americans have lower rates of colorectal cancer (CRC) screening, later stage of diagnosis and poorer survival relative to other racial/ethnic groups. To address this disparity, the investigators developed a multi-component intervention to increase CRC screening and have determined its efficacy in a randomized trial (Maxwell,et. al., 2010). This study aims to determine how an intervention to increase CRC screening can best be integrated within the cultural norms and existing structures of churches and community based organizations (CBOs) with predominantly Filipino American membership to ensure broad dissemination to those in need of screening. The investigators will provide our partner CBOs with resources and technical assistance, including training of community volunteers as health advisors, to enable them to promote CRC screening to their constituents. Using a scientifically rigorous research design, the investigators will compare two dissemination strategies: Basic dissemination which consists of a single kick-off event during which community health advisors will receive print materials and FOBT kits for distribution and training on how to conduct educational small-group sessions; and Organizational dissemination aimed at integrating CRC screening dissemination into organizational practices and processes that can be sustained after the end of the study. The study will be implemented in 20 CBOs and will train 100 community health advisors (CHAs). The impact of the two dissemination strategies will be comprehensively assessed by collecting data at the CBO level, from the CHAs and from 1000 Filipino American participants. The investigators will compare the proportion of Filipino American participants who obtain CRC screening by dissemination strategy, but the investigators will also assess how many are reached, if the intervention is implemented as planned, how CBOs support the screening efforts at their regular activities, and if CBOs and CHAs maintain their efforts over the 4 years of the study. The investigators hypothesize that CBOs can implement evidence-based strategies to promote CRC screening and CHAs in the organizational dissemination arm will reach more participants and more screened participants than CHAs in the basic dissemination arm; and organizations in the organizational dissemination arm will adopt more CRC screening activities and maintain these better than organizations in the basic dissemination arm.

NCT ID: NCT01346839 Completed - Prostate Cancer Clinical Trials

Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care

Start date: February 2011
Phase: N/A
Study type: Interventional

Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are called back to conduct timely investigations when appropriate. To achieve high standards of patient safety in cancer diagnosis, the investigators not only need to use information technology appropriately but also improve the processes, policies, and procedures of monitoring, communication, and coordination of care. Given the importance of cancer-related diagnostic delays in ambulatory care, the investigators need effective methods to detect them, understand their causes, and intervene to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and random chart reviews, have limited effectiveness. Our proposed study focuses on testing methods to proactively identify delays using certain "triggers" as they occur and intervene in a timely manner.

NCT ID: NCT01344330 Completed - Colon Cancer Clinical Trials

Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Start date: January 2012
Phase:
Study type: Observational

This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake.

NCT ID: NCT01310972 Completed - Colon Cancer Clinical Trials

Adjuvant Colon Cancer w/ ELOXatin®/5 FU Based Regimen: ACCELOX

Start date: September 2007
Phase:
Study type: Observational

Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX

NCT ID: NCT01287130 Completed - Colon Cancer Clinical Trials

AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer

Start date: January 7, 2011
Phase: Phase 1
Study type: Interventional

Background: - The experimental cancer treatment drug AZD6244 has been shown to block signals that tell cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon, and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating the highest safe dose of AZD6244 to give with cetuximab, and will also investigate the effectiveness of this drug combination in individuals who have colorectal cancer that involves a particular protein known as the K-RAS protein. Cetuximab is not used to treat colorectal cancer with K-RAS tumors because it has not been shown to be effective, but researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab works, even in people with K-RAS tumors. Objectives: - To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for solid tumors that have not responded to standard treatment. - To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for colorectal cancer that involves the K-RAS protein and has not responded to standard treatment. Eligibility: - Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatment. - Individuals at least 18 years of age who have been diagnosed with colorectal cancer that has not responded to standard treatment. Design: - This protocol will involve two separate studies: an initial study to establish the highest safe and effective dose of AZD6244 and cetuximab in individuals with solid tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal cancer involving the K-RAS protein. - Participants will be screened with a full medical history and physical examination, blood samples, imaging studies, and other tests as required by the researchers. - AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an empty stomach. Cetuximab will be given intravenously once a week, over 2 hours for the first dose and over an hour for every following dose. This combination of daily AZD6244 and weekly cetuximab will be repeated in 28-day cycles of treatment. Participants will keep a diary to record the time of taking AZD6244 each day, as well as any side effects. - Participants will have frequent blood tests and other exams during the first cycle of treatment, up to five visits to the National Institutes of Health (NIH) and other visits to their local doctor to in the first 28-day cycle. - During subsequent cycles, participants will have four visits to NIH and four visits to your local doctor for examinations, blood tests, and imaging studies. - Participants may continue to receive the AZD6244 with cetuximab for up to 6 cycles, until the tumor grows, unacceptable side effects development, or the participant or participant's doctor decides to stop participation. There will be a final study visit that repeats the procedures performed during the screening visit....

NCT ID: NCT01251237 Completed - Colon Cancer Clinical Trials

Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies

Start date: March 2010
Phase: Phase 2
Study type: Interventional

It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well established as safe and effective agents for gut cleansing and Norgine has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient acceptance. Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in subjects' compliance with gut preparation procedure. The study medication NRL0706 is identical to the PEG+E-containing gut lavage solution commonly used in clinical practice, with the exception that the flavour has been modified from lemon to orange. This study is to investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706 (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for colon cancer screening.

NCT ID: NCT01222208 Completed - Colon Cancer Clinical Trials

Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients

Start date: March 2011
Phase: N/A
Study type: Interventional

A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.