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Current Research Projects __________________________________ For more information on cancer and comorbidity and a link to the online course: Click Here For more information on current tinnitus research protocols: Click Here The Clinical Outcomes Research Office (CORO) is a research laboratory dedicated to studying the outcomes of health care interventions. Please click on the links above to learn more about current cancer and comorbidity studies as well as current tinnitus (ringing in the ears) studies. A comprehensive list of all studies available within the CORO is also detailed below.ing the outcomes of health care interventions. Current Research: 06-0136-Comparison of Comorbidity Collection Methods The goal of this research is to assess which co-morbidity collection method, chart-based or claims-based, is best for hospital-based cancer registries. We are interviewing oncologists to obtain their unique insight into the types of co-morbidity information they need in order to take better care of cancer patients. During the interview, oncologists will be asked to compare the claims-based ICD-9 system currently in use by cancer registrars with a chart-based, severity-graded system. The oncologists’ interviews will be used to assess which collection method provides the most useful, comprehensive, and beneficial cancer information for physicians. 07-1082- Development of a Comprehensive Prediction Model for Colon Cancer The American Joint Committee on Cancer TNM staging system is the gold standard for the prognostication of colon cancer.  However, this system is limited in its ability to provide the most accurate prognostic information since it is purely a morphologic system and ignores important patient-based prognostic factors, like co-morbidity.  Colon cancer has a genetic etiology and better knowledge of the complement of genetic events that lead to neoplastic transformation may allow for improved prediction of a tumor’s biologic behavior. There are three basic and distinct genetic pathways that can lead to the development of adenocarcinoma of the colon.  As a result, there is significant heterogeneity among a given cohort of colon cancer patients.  Unfortunately, the majority of research attempting to identify useful prognostic genetic and molecular markers has been limited to one or two genes.  As a result, the data have been inconsistent. The broad long-term objective of this project is to improve the present cancer staging system for colon cancer through the inclusion of statistically significant and independent patient-based factors and molecular tumor markers. In order to more fully explore the prognostic performance of patient-based and molecular markers, we will explicitly explore the impact of specific patient and tumor characteristics such as race, co-morbidity, and pathologic features.  There are two specific aims. One is to develop and validate comprehensive prognostic models that incorporate cogent molecular markers along with other patient and tumor prognostic factors. Another aim is to explore black/white differences in the presence of different molecular markers and explore the prognostic implications of different molecular markers in African-American and white patients. Behavior of certain genes, such as oncogenic mutation, tumor-suppressor gene mutation, allelic loss of chromosomes, infiltration of immune cells, and microsatellite instability have each been evaluated as potential prognostic factors in disease progression, disease recurrence, disease-free survival, and overall survival and as predictive factors of response to therapy.  By evaluating an established set of genetic markers that encompasses the spectrum of genetic events involved in colon cancer development as well as markers that are involved in a patient’s innate response to a neoplastic process, a useful model for prognostication can be developed. The results from this pilot study will be used as preliminary studies for future NIH grant application. 08-0502-Survival Using Co-morbidity Data The inclusion of co-morbidity information in cancer registries will improve the accuracy of survival statistics and the evaluation of treatment effectiveness, which may eventually lead to a decrease in mortality and better quality of life for cancer patients. Because of the importance of co-morbidity to cancer care, many organizations plan to include co-morbidity as a required data element for cancer registries.  Cancer registrars at Barnes-Jewish Hospital-Oncology Data Services (BJH-ODS) abstract co-morbidity information from patients’ charts using both a chart based and a claim based method. The investigators will receive via an electronic submission, de-identified data previously collected as part of standard tumor registry practice by registrars at BJH-ODS on analytical cases (first diagnosed and treated at BJC healthcare). Data will be used to investigate how addition of co-morbidity data influences survival for cancers of different body systems and how this information can be used by cancer patients and physicians trying to predict their survival and better plan their treatment. Survival will be the primary outcome of interest. Statistical models generated from the survival analysis will be used to generate curves for prediction of survival. A website available to the public and physicians will be created to introduce these curves. De-identified individual information will be requested and upon receipt, a personalized survival curve will be built for each individual. The website is currently under construction. 09-0433-A Comprehensive Assessment of Adult Head and Neck Cancer Survival In the United States, the incidence of cancer is increasing as our population ages.  Survivorship has dramatically improved within the last four decades and so a greater number of Americans are living after cancer diagnosis. Survivorship research focuses on the health and quality of life of a person with a history of cancer beyond the acute diagnosis and treatment phase.  Adult cancer patients often have other coexisting illnesses or health conditions unrelated to their index cancer.  These patients may be experiencing age-related physiological changes, co-morbidities, and cognitive or functional impairments at the time of their cancer diagnosis and even after cancer therapy.  Our aim is to increase our understanding of the complex interaction among human aging, cancer, and co-morbid health ailments by evaluating physical, functional, and cognitive changes that occur in adult cancer patients during the course of cancer treatment. Twenty participants with newly diagnosed head and neck cancer will be enrolled. Our study will use both subjective or self-report questionnaires and objective or performance-based assessments to evaluate cognitive and functional health status at two time-points: 1. Baseline (before any treatment modality) 2. Post-therapy (chemotherapy, radiation or surgery) Data obtained will be analyzed using the SAS® program for obtaining descriptive statistics as well as for investigating statistically significant changes in health status between the time-points evaluated. It is our belief that the additional neuropsychological and performance-based testing used in this study will be more sensitive in detecting both subtle and overt cognitive changes that occur as a result of anti-neoplastic therapy in head and neck cancer adult survivors. 09-0474- Adjuvant chemotherapy in elderly patients with colorectal cancer The results of previous analyses of clinical trial participants cannot necessarily be extrapolated to patients treated in routine practice whose co-morbidities may make them ineligible for clinical trials. The impact of co-morbidities and their relationship with advancing age on receipt of adjuvant chemotherapy and survival in patients with Stage II/III colorectal cancer treated in routine practice is not well-defined. This study will elucidate the relative impacts of age and co-morbidity on survival in patients with stage II/III colorectal cancer.  It will also quantitate whether adjuvant chemotherapy improves survival in this cohort. The results of this study will help clinicians and patients make decisions about adjuvant chemotherapy for locally advanced colorectal cancer, a decision which is often complex in the face of co-morbid medical conditions. B-08-23-Prognostigram For many years, prognostic estimates and decision-making in cancer were based on 5-year survival statistics published by the American Joint Committee on Cancer and the American Cancer Society. These data relate mortality to site and TNM staging, but do not account for patient-specific factors such as other medical conditions, referred to as co-morbidities, which have been shown to be independent predictors of cancer survival in several studies. The Prognostigram, a computer software program developed here by our team, attempts to generate graphic representations of patients’ chances for survival based on cancer diagnosis and follow-up survival information, while also taking into consideration the impact that their co-morbidities, sex, age, race, tumor site, and tumor stage may have on their survival. As a first step in preparing the Prognostigram program for public use, we aim to gather feedback from potential users through our study.  In particular, we would like to gather feedback from individuals (a total of 20 participants) who have been recently diagnosed with one of the following types of cancers: breast, cervical, colorectal, head and neck, liver, prostate, esophageal, lung, stomach, small intestine, pancreatic, renal, ovarian, uterine, and bladder. As a part of the study, participants will undergo an interview exploring the following concepts: Attitudes regarding survival statistics and how patients would best prefer it be presented Patients’ understanding of their own survival statistics as presented by the Prognostigram Patients’ visual aid preference for presentation of statistical survival information (computer-based visual aids versus hard copy visual aids). Our hope is that data obtained from this study will not only provide the much needed information that would help in developing a patient-friendly software, but that would also help in the advancement of cancer management as we know it today, specifically with regards to prognosis and the ensuing patient journey. 07-0689-Collaborative Tinnitus Research at Washington University There is no known medication that cures tinnitus (ringing, buzzing, whistling noise in the ears). About 40 million people in the United States experience chronic tinnitus and 10 million of these people consider their tinnitus to cause significant problems in their daily lives. The sounds patients hear when they are bothered with tinnitus most likely originate inside the brain in an area just above and behind the ear, the “auditory cortex”. Treatment for tinnitus using an electro-magnetic device named rTMS (repetitive Transcranial Magnetic Stimulation) is being studied. The use of rTMS for tinnitus is investigational (not FDA approved). Research continues to be done around the world to look at establishing the safety and efficacy of rTMS as a treatment for tinnitus. rTMS works by placing the magnetic instrument against the scalp, near the auditory cortex, and delivering a magnetic stimulus to the brain. Medical researchers believe that rTMS stimulation causes the area of the brain associated with tinnitus to become less active and that the result maybe be a diminished sound of tinnitus. It is important to understand that some rTMS tinnitus research studies have reported that rTMS works well and some have reported that rTMS does not work to stop tinnitus. The purpose of this study is to investigate the safety and the effective use of rTMS to treat people suffering from tinnitus. This study hopes to add to the medical knowledge about how tinnitus responds to rTMS treatments. 09-0551-rTMS To The Dorsolateral Prefrontal Cortex For Patients with Subjective There is growing recognition that  the bothersome features of tinnitus originate inside the brain and not directly inside of the ear. The bothersome tinnitus sounds seem to be caused by the brain “paying too much attention” and eliciting too strong an emotional response to the auditory stimulation.. This pilot study examines the impact of treating the dorsolateral prefrontal cortex (DLPFC) area of the brain. The DLPCF controls mood and also plays a part in attention and is thought to be responsible for awareness of the tinnitus. The treatment intervention is called repetitive Transcranial Magnetic Stimulation or rTMS. It involves placing an electro-magnetic device on the scalp and stimulating the brain. Treatment for tinnitus has been studied here at Washington University by Drs. Piccirillo, Garcia, Jarvis, and Hullar. rTMS is approved by the Food and Drug Administration (FDA) for the treatment of major depression; however, it is still investigational when doctors use rTMS to treat tinnitus. The use of electromagnetic stimulation in the treatment of tinnitus was first reported in 1993. Research continues to be done around the world to look at establishing the safety and efficacy of rTMS as a treatment for tinnitus. It is important to understand that some rTMS tinnitus research studies have reported that rTMS works well and some have reported that rTMS does not work to stop tinnitus. During rTMS a magnet is placed against the scalp, on the forehead above the left eye, and produces a magnetic stimulus near the area of the brain called the left dorsolateral pre-frontal cortex (DLPFC). Medical researchers believe that stimulating the brain with rTMS in the DLPFC will cause the sounds to become less bothersome. It is thought that by treating this area, patients may be better able to ignore the tinnitus. 09-0481-Exploring Voluntary Control of Tinnitus Certain patients report that they are able to modulate the loudness or pitch of their tinnitus temporarily through various means, including attention re-direction or somatosensory mechanisms such as oral facial movements or head turning. This subset of patients may represent a unique opportunity for the researcher to gain insight into the mechanisms responsible for tinnitus. Neural activity in the brain has been linked to increases in blood flow and blood oxygenation. These changes in the concentration of oxyhemoglobin versus deoxyhemoglobin alter the magnetic resonance signal of blood which may then be detected using an appropriate MR pulse sequence as blood-oxygen-level-dependent (BOLD) contrast. In addition to increases in blood flow due to evoked neural activity, the brain exhibits continuous low frequency spontaneous activity. These fluctuations tend to be synchronous in functionally related, but spatially distinct, regions of the brain even when not performing a prescribed task. The phrase functional connectivity has been used to implicate the neural activity that facilitates the coordinated activity of functionally related brain regions. This study will use functional connectivity magnetic resonance imaging (fcMRI) to measure the network of synchronous brain activity in patients with tinnitus. Several targeted networks are those linked to the auditory system, attention, and control systems and the emotion systems linked to prefrontal cortex. Previously, functional MRI (fMRI) used changes in blood flow and blood oxygenation within the brain to detect which isolated regions of the brain were active during a task. The goal of functional connectivity research is to describe a pattern of interactions or a picture of the connectivity that occurs within distinct regions of the brain when the individual is not involved in a task.