2004project95DiMaio

Request for Funding

Mentor: J. Michael DiMaio, M.D.
Department: Cardiovascular and Thoracic Surgery
Room number: HA9.154
Mail Code: 8879
Phone number: (214) 645-7731
E-mail: Michael.dimaio@utsouthwestern.edu

Six Projects

Project I title: CLINICAL IMPACT OF COMBINED MODALITY THERAPY FOR ESOPHAGEAL CANCER

Human subjects IRB approved project number (where applicable): # 1103-749.

Animal subjects IRB approved project number (where applicable):

Project Type: Patient-Based Research

Brief Description of Project:
The project will consist of a retrospective chart review and statistical analysis. From this information an abstract and paper will be produced. The purpose of this study is to complete a broad chart review of all the patients with esophageal cancer who have been treated in the UT Southwestern Hospital System (St. Paul University Hospital, Zale Lipshy University Hospital, Veteran's Hospital, and Parkland Health and Hospital System) from 1994-2004. This study will look at the incidence and prevalence of the different types of esophageal cancer with respect to ethnicity, sex, and age. The study will also consider the association of esophageal cancer with certain habits, such as smoking and alcohol use. We will also compare the different treatment modalities with the aim of indicating which has the best outcome while taking into account the complications and morbidity involved with each treatment.

Project II

X PURPOSE: The objective of this study is to take a retrospective look at the occurrence, presentation, interventions and outcomes of renal cell carcinoma at UT Southwestern Medical Center's Hospital System from 1990-2004.
X BACKGROUND: Both incidence and mortality from renal cancer have been rising since 1950. The true incidence is also probably higher than reported, as undiagnosed renal cancer is not uncommonly found at post mortem. Unfortunately by the time most patients present with symptoms and physical findings the disease is likely to be metastatic.
Five-year survival for all stages is about 50 per cent, but for the 20-30 per cent of patients presenting with metastatic disease it is only 5-10 per cent, with most deaths within the first two years. Over the last four decades the prognosis from renal cell cancer has improved, most likely due to earlier detection due to changes in radiological investigations and therefore more curative operations. More studies are required to further elucidate which treatment option is best and to try to improve the 5-year cure rate, while at the same time reducing complications and morbidities of treatment.
X CONCISE SUMMARY OF PROJECT: The purpose of this study is to complete a broad chart review of all the patients with renal cell carcinoma who have been treated in the UT Southwestern Hospital System (St. Paul University Hospital, Zale Lipshy University Hospital, Veteran's Hospital, and Parkland Health and Hospital System) from 1990-2004. This study will look at the incidence and prevalence of the different types of renal cell carcinoma with respect to ethnicity, sex, and age. The study will compare the different treatment modalities with the aim of indicting which has the best outcome while taking into account the complications and morbidity involved with each treatment.
X CRITERIA FOR INCLUSION OF SUBJECTS: To be included in this study, subjects will be required to have been treated for renal cell carcinoma at UT Southwestern Medical Center's Hospital System between1990-2004. Age, gender, race, ethnic background, life expectancy, nutritional status, performance status, organ function, or recovery from prior treatment will not be taken into account in determining who is eligible for this study. The only requirement to be included is that the subject was treated for renal cell carcinoma at UTSWMC between1990-2004.
X CRITERIA FOR EXCLUSION OF SUBJECTS: Individuals who have never been treated for renal cell carcinoma at UTSWMC will be excluded from this study.
X SOURCES OF RESEARCH MATERIAL: Existing medical records will be used. Study coordinators and investigators will have access to the patient's medical records. The data will contain patient identifiers: medical record number and social security number. The data to be reviewed will include a chart review of their complete medical history, physician's progress notes/physical examination report, laboratory data, medication administration information, x-ray, MRI and other test results. The information obtained from the medical record will be recorded onto a data collection form. The subject will be assigned a project identifier, which will be recorded on the data collection form, and will correspond to a master list which will be locked in the study coordinators office. Use of this data will be restricted to research purposes only and all patient identifiers will be destroyed when the research is completed (6 months).
X RECRUITMENT OF SUBJECTS: Dr. DiMaio will recruit his own patients with the assistance of the study coordinator and study investigators who have received a combined modality of treatment for renal cell carcinoma. We do not wish to contact these patients.
X POTENTIAL RISKS: The risks associated with this research are minimal as long as there is no breach of confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would comprise a high or moderate level of expected risk. In order to protect the participant's private health information from potential harm, the information will be stored securely and kept confidential. Only the researchers will have access to the data.
X SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.

X PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in connection with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subject initials and study identification number. Information gained from this study, including the completed data collection forms will be kept locked in the study coordinator's office and released only to the investigator, and study site personnel. Review of medical records or any other research records pertaining to the research subject will be done onsite for verification purposes only. All patient identifiers will be removed prior to removing from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be held strictly confidential and no disclosures of personal identity will be allowed.

Members and staff of the IRB may review these records in an effort of quality control.
X POTENTIAL BENEFITS: There are no direct benefits to subjects whose medical records are used for this study. However, the knowledge gained from this research may help other similarly affected patients and society as a whole by revealing new information so that physicians may contribute to the better understanding and treatment of renal cell carcinoma.
X BIOSTATISTICS: We will use biostatistics to compare morbidity and mortality in various patient groups.

X RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and treatment of renal cell carcinoma.

Project III Summary

PURPOSE: Through retrospective analysis, we hope to develop strategies to decrease the likelihood of thoracostomy tubes being placed into the parenchyma of the lung.
BACKGROUND: As our experience with chest CT scans has increased, it has become clear to us that placement of thoracostomy tubes into the lung parenchyma is not a rare event. Complications that may arise because of a misplaced thoracostomy tube include: bleeding, or persistent air leak with pneumothorax. This may predispose the patient to subsequent infection. From this study, we hope to gain information to be able to develop strategies to decrease the likelihood of this unfortunate complication.
CONCISE SUMMARY OF PROJECT: We plan to study the circumstances in which these malpositionings occur, the roentgenographic and CT findings displayed, the clinical complications which result, and the treatment employed. We hope to develop strategies to decrease the likelihood of this mishap, and to optimize therapy.
CRITERIA FOR INCLUSION OF SUBJECTS: Patients must have been treated at Parkland Health and Hospital System, St. Paul University Hospital or Zale Lipshy University Hospital from January 1998 until April 2004 for complications due to the misplacement of a thoracostomy tube. Patients must be over the age of 18. Age, gender, race, ethnic background, life expectancy, nutritional status, performance status, organ function, or recovery from prior treatment will not be taken into account in determining who is eligible for this study.
CRITERIA FOR EXCLUSION OF SUBJECTS: Patients who have received a thoracostomy tube and it has not been placed into the lung parenchyma or those patients who did not received a chest tube will not be included in this study.
SOURCES OF RESEARCH MATERIAL: Existing medical records will be used. Study coordinators and research investigators will have access to patient medical records. The data will contain patient identifiers that will be recorded: social security numbers and medical record numbers. The data to be reviewed will include a chart review of the patient's complete medical history, physician's progress notes/ physical examination reports, laboratory data, medication administration information, x-ray, MRI and other test results will be recorded. The information to be collected will be recorded onto a data collection form (attached). The subject will be assigned a project identifier, which will be recorded on the form, and will correspond to a master list which will be locked in the study coordinator's office. Use of this data will be restricted to research purposes only and all patient identifiers will be destroyed at the completion of this project (6 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio, with the assistance of the research coordinator, will recruit his own patients who have been treated for complications arising because of a misplaced thoracostomy tube.
POTENTIAL RISKS: The risks involved in this research are minimal, as long as there is no breach in patient confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would compromise a high or moderate level of expected risk. In order to protect the patient's private health information from potential harm, the information will be stored securely and kept confidential. Only researchers will have access to this information.
SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.

PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in association with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subject initials and study identification number. Information gained from this study, including the completed data collection forms will be kept locked in the study coordinator's office and released only to the investigator, and study site personnel.

Review of medical records or any other research records pertaining to the research subject will be done onsite for verification purposes only. All patient identifiers will be removed prior to removing from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be held strictly confidential and no disclosures of personal identity will be allowed.

Members and staff of the IRB may review these records in an effort of quality control.
POTENTIAL BENEFITS: There are no direct benefits for those whose medical records are reviewed. However, the knowledge gained from this research may help other similarly affected patients and society as a whole by revealing new information so that physicians may contribute to the better understanding and treatment of pulmonary masses.
BIOSTATISTICS: Application of statistics to the analysis of biological and medical data will be used. Characteristics to be analyzed will include morbidity and mortality among patients with pulmonary masses.
RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding of the circumstances in which these malpositionings occur and aid in the development strategies we can implement to ensure that this becomes a rare event.

Project IV Summary

PURPOSE: The objective of this study is to take a retrospective look at the occurrence, presentation, interventions and outcomes of lung cancer in heart and/or lung transplant patients at UT Southwestern Medical Center's Hospital System from 1988-2004.
BACKGROUND: Primary bronchogenic carcinoma remains the leading cause of cancer death in non-transplant patients, and cigarette smoking is the predisposing factor for end-stage cardiopulmonary disease. The incidence of lung cancer in heart and/or lung transplant patients is a primary concern that stems from the increased incidence with immunosuppresion. Lung cancer remains one of the more aggressive and variant types of cancer with a relative risk for metastasis. The risk of lung cancer in post-transplant patients on prolonged nonspecific immunosuppression is higher than the risk of lung cancer in non-transplant patients. Prognosis for various cancers, especially lung cancer, is low, and carcinoma is the most frequent cause of non-graft related deaths after transplantation.
CONCISE SUMMARY OF PROJECT: The purpose of this study is to complete a broad chart review of all transplant patients with lung cancer who have been treated in the UT Southwestern Hospital System (St. Paul University Hospital) from 1988-2004. This study will look at the incidence and prevalence of the different types of lung cancer after heart/lung transplantation with respect to ethnicity, sex, and age. The study will also consider the association of lung cancer with certain habits, such as smoking. We will also consider the effectiveness of screening for cancer, and the consequent modalities for treatment will be compared to determine which has the best outcome, taking into account the complications and morbidity involved in each case.
CRITERIA FOR INCLUSION OF SUBJECTS: Subjects will be required to have had a transplant and subsequent lung carcinoma diagnosis at any of the above mentioned UTSWMC hospitals from 1988-2004. Age, gender, race, ethnic background, life expectancy, organ function, nutritional status, or performance will not be taken into account. The only requirement is to have had a heart or lung transplant and subsequent lung cancer diagnosis at any UTSWMC hospital from 1988-2004.
CRITERIA FOR EXCLUSION OF SUBJECTS: Healthy individuals who have never been had a heart or lung transplant at any of the above mentioned UTSWMC hospitals from 1988-2004.
SOURCES OF RESEARCH MATERIAL: Existing records and medical data will be used. Study investigators and coordinators will have access to the patient's medical records. The data will contain patient identifiers, name, medical record number, social security number. The data to be reviewed will include a chart review of their complete medical history, physician's progress notes/physical examination report, laboratory data, medication administration information, x-ray, MRI and other test results. Use of this data will be restricted to research purposes only and patient identifiers will be destroyed when the research is completed (6 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio will recruit his own patients with the assistance of the sub-investigators and study coordinators. We do not wish to contact these patients.
POTENTIAL RISKS: The risks associated with this research are minimal as long as there is no breach of confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would comprise a high or moderate level of expected risk. In order to protect the participant's private health information from potential harm, the information will be stored securely and kept confidential. Only the researchers will have access to the data.
SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.

PROCEDURES TO MAINTAIN CONFIDENTIALITY: Any information that is obtained in connection with research that can be identified with a subject must remain confidential and can be disclosed only with a subject's permission. All study records will be identified by the subject initials and study identification number. Subject identifiers (name, MR#, SS#, etc.) will not be used. Information gained from this study, including the completed data collection forms will be kept locked in the study coordinator's office and released only to the investigator, and study site personnel. Review of medical records or any other research records pertaining to the research subject will be done onsite for verification purposes only. All patient identifiers will be removed prior to removing from campus. Only researchers and research coordinators will have access to the data obtained. All medical information will be held strictly confidential and no disclosures of personal identity will be allowed.

Members and staff of the IRB may review these records in an effort of quality control.
POTENTIAL BENEFITS: There are no direct benefits expected to patients for their participation in this study. The data accumulated in this study may help other similarly affected patients and society as a whole by revealing new information so that physicians may contribute to the better understanding and treatment of lung cancer after heart transplantation with the aim of improving the ability to diagnosis the neoplasm at an earlier stage.
BIOSTATISTICS: There will be no biostatistics done with this data.
RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and treatment of esophageal cancer.

Project V Summary

PURPOSE: The objective of this study is, through retrospective analysis, to determine the effectiveness of PET-CT data in differentating if patients with pulmonary masses have neoplastic disease or active granulomatous disease.
BACKGROUND: PET scanning is the current imaging procedure of choice for differentiation of benign from malignant pulmonary tumor. In lesions greater than 1.5 cm PET has a negative predictive value greater than 95%. However the positive predictive value is only 80 to 85 % as a result of false positive PET scans due primarily to granulomatous disease.

The PET scan diagnosis of cancer is based on the increased accumulation of glucose as measured by the Standard Uptake Value (SUV). Unfortunately active granulomatous disease may also have a high SUV. Thus some patients may undergo unnecessary surgery for a benign inflammatory condition that is PET scan positive.

Computerized Axial Tomography (CT) scanning has been used in the past to distinguish granuloma from neoplasm based on the increased density of calcification within the granuloma. The success of this approach has been modest, at best, since many granulomas do not have enough calcium to be distinguished as benign.
Recently PET-CT scans have been performed as a combined examination with the CT data used primarily to provide anatomic information for aid in interpreting the PET. The CT density data in conjunction with the PET SUV has not been used to aid in characterizing the lesion histology.
CONCISE SUMMARY OF PROJECT: We propose to review retrospectively the PET- CT data on patients with pulmonary masses that have been verified by histologic diagnosis. We are interested in determining if some combination of SUV and CT density and morphology can aid in differentiation of neoplasm from granulomatous or other benign processes.
CRITERIA FOR INCLUSION OF SUBJECTS: To be included in this study, patients must have received a PET-CT scan positive for pulmonary masses. In addition, the pulmonary masses must have proven histologic diagnosis. And finally, the patient must have been treated at one of the UT Southwestern Medical Center's Hospitals between January 2003 and April 2004. Age, gender, race, ethnic background, life expectancy, nutritional status, performance status, organ function, or recovery from prior treatment will not be taken into account in determining who is eligible for this study.
CRITERIA FOR EXCLUSION OF SUBJECTS: Patients who have pulmonary masses, but did not received a PET-CT scan, or have a histologic diagnosis will not be included in this study.
SOURCES OF RESEARCH MATERIAL: Existing medical records will be used. Study coordinators and research investigators will have access to patient medical records. The data will contain patient identifiers that will be recorded: social security numbers and medical record numbers. The data to be reviewed will include a chart review of the patient's complete medical history, physician's progress notes/ physical examination reports, laboratory data, medication administration information, x-ray, MRI and other test results will be recorded. The information to be collected will be recorded onto a data collection form (attached). The subject will be assigned a project identifier, which will be recorded on the form, and will correspond to a master list which will be locked in the study coordinator's office. Use of this data will be restricted to research purposes only and all patient identifiers will be destroyed at the completion of this project (6 months).
RECRUITMENT OF SUBJECTS: Dr. DiMaio, with the assistance of the research coordinator, will recruit his own patients who have been treated for pulmonary masses, discovered by PET-CT scans and have histologic diagnosis. We do not wish to contact these patients
POTENTIAL RISKS: The risks involved in this research are minimal, as long as there is no breach in patient confidentiality on the part of the researchers. The questions to be asked are not sensitive or of a personal nature that would compromise a high or moderate level of expected risk. In order to protect the patient's private health information from potential harm, the information will be stored securely and kept confidential. Only researchers will have access to this information.
SPECIAL PRECAUTIONS: Subject's right of confidentiality will be given strict priority. No mention of the subjects' identifiers will be made directly or indirectly in oral or written presentation of this work.

RISK/BENEFIT ASSESSMENT: The risks to the subject are minimal. The anticipated amount of knowledge acquired will improve our understanding and treatment of pulmonary masses.

Project VI title: Expected Management of Traumatic Aortic Injury

Human subjects IRB approved project number (where applicable): pending

Animal subjects IRB approved project number (where applicable):

Project Type: Patient-Based Research

Brief Description of Project:

The project will consist of a retrospective chart review with the goal of determining how to treat traumatic aortic injury. I will use statistical analysis to determine whether it is better in terms of the patient's long-term prognosis to treat aortic trauma at the time of injury or to wait until comorbid injuries have begun to heal.

Previous Research Activities or Publications with Medical Students:
" Infective Endocarditis: Clinical Course and Results of Surgical Management
" Pain Management Techniques used in the Postoperative Period following Thoracotomy Procedures - A Retrospective Analysis and Followup
" Clinical Management of Laryngotracheal Trauma: Case Report and Literature Review

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