The Mesothelioma Applied Research Foundation Clinical Research Project
Collection of CLINICAL DATA, Serum, Blood cells, and tissue samples from patients with biopsy-proven or suspected MESOTHELIOMAS
Objectives
Primary Objective. The primary objective of this study is to collect clinical data, serum, blood cells, and tissue samples from patients with mesothelioma for use in Mesothelioma National Data/Tissue Bank initiated in cooperation with UCLA and the Mesothelioma Applied Research Foundation (MARF).
Secondary Objective. The secondary objective is to act as a tissue bank to provide material for future research for the investigators, MARF physicians, and collaborators.
Background and Significance
Background. Mesothelioma is a deadly malignancy that affects an unknown number of people in the U.S. and throughout the world each year. Due to the relatively small numbers involved compared to other major cancers, mesothelioma has been essentially ignored for nearly 40 years. Patients are treated at a variety of centers throughout this country with poorly documented results. It is imperative that a centralized databank be established in order to understand the natural history of the disease and the outcomes from treatments currently being used as well as those developed in the future, to better evaluate the benefits of the various current treatment approaches, and to best evaluate and prove effectiveness of future novel therapies. In addition, a parallel tissue bank would be invaluable in the analysis of tumors for more rational treatment planning in the future. The Mesothelioma Applied Research Foundation (MARF), with its national group of committed mesothelioma physicians and researchers, has teamed up with UCLA to initiate this project as a high priority.
Significance. Ongoing as well as future research in patients with mesothelioma within the medical community depend on the availability of serum, blood cells, and tissue samples from patients with malignant disease. Specifically, current and planned research projects often require serial serum and blood cell samples from cancer patients throughout the course of their disease (to correlate novel experimental results with developments in the clinical course of the patient's disease) as well as cancer tissue obtained from these patients at the time of planned surgery. With appropriate access to these serum, blood cell, and tissue samples, research projects within the medical community will be able to identify novel methods of cancer treatment using the immune system and possibly new substances to block biologic pathways in cancer cells. Collaboration between the Mesothelioma Applied Research Foundation (MARF) and a number of institutions has provided a unique ability to establish a national data and tissue bank for use in mesothelioma research.
Subject Population
Eligibility Requirements. All patients with biopsy-proven or suspected malignant mesothelioma are eligible. All patients who are seen by thoracic surgeons within the Department of Surgery, medical oncologists within the Department of Medicine, and radiation oncologists within the Department of Radiation Oncology will be evaluated by their attending physician for their suitability for serum, blood cell, and tissue collection.
Patient Accrual Goals. In order to maximize the utility of the information and tissue collected, it is estimated that approximately 5000 patients with pathologically documented malignancies will be needed over the next 5 years. Therefore, an accrual of approximately 1000 patients/year is anticipated. This will be obtained through the collaboration of multiple centers throughout North America, including the Mesothelioma Applied Research Foundation (MARF).
Design/Methodology
Patient Participation. All patients with biopsy-proven or suspected malignant mesothelioma will have clinical data and blood samples collected. In addition, a sample of normal as well as malignant tissue will be taken at the time of planned surgery. This collection will in no way interfere with the adequate pathologic evaluation of the specimen or in the health of the patient. If there is any doubt as to the necessity for all tissue to be pathologically reviewed, none will be harvested. In addition, if the patient develops severe anemia, particularly if blood transfusion is being considered, no blood will be collected.
Procedures. The following procedures will be performed as part of this protocol:
Data collection. At the time of initial patient evaluation and/or during subsequent patient encounters, medical records will be collected and entered into a national mesothelioma data registry maintained at UCLA Medical Center in cooperation with the Mesothelioma Applied Research Foundation (MARF). All data will be sent by facsimile to the data center at UCLA Medical Center and then coded with a unique identification number as the sole identifying information. All personal information will be removed. A log that identifies the patients and their identification numbers will be kept in a locked file cabinet in the office of the principle investigator at UCLA. The only people who will have access to the code will be Dr. Robert Cameron and the data entry and study nurse. The anonymous data will be available for researchers to analyze following approval of a research proposal. The proposal will be reviewed by a committee chaired by Dr. Cameron and consisting of members of the MARF Scientific Advisory Board. This process will occur through MARF as a "clinical" research protocol.
Blood collection. At the time of initial patient evaluation and/or during subsequent patient encounters, 100 cc of blood (approximately 3.3 oz or 4 tablespoons) will be drawn into tubes with heparin anticoagulant. A maximum of twelve (12) specimens will be obtained from each patient over no less than 12 weeks. Tubes will be labeled wit the patient's name, identifying information, and the time and date of blood collection. These samples will be transported to the Mesothelioma National Data/Tissue Bank Laboratory (currently room 62-151 CHS at UCLA Medical Center). The blood will then be centrifuged, and the serum will be collected, frozen, and entered into a computerized tissue bank. The peripheral blood mononuclear cells also will be collected, washed, cryopreserved, and stored.
Tissue collection. No tissue will be removed from patients solely for use in this protocol. However, if tissue is removed from patients in this protocol during the normal course of treatment, a portion of the excised malignant and/or normal tissue may be separated from the main specimen by the surgeon for storage in the National Mesothelioma Data/Tissue Bank. The surgeon will work directly with the pathologist to insure that removal of any tissue will not compromise the accurate pathologic assessment of the malignancy. Tissue samples will be transported to the Mesothelioma National Data/Tissue Bank Laboratory (currently room 62-151 CHS at UCLA Medical Center). The tissue will then be processed for RNA, DNA, protein, and whole cells (if available), frozen, and entered into a computerized tissue bank.
Treatment Plan. Standard treatment for individual malignancies will be followed at all times. Patients admitted to this protocol will not be admitted to protocols of experimental treatments unless they also specifically meet the eligibility requirements and sign informed consent for experimental protocols approved by the Human Subjects Protection Committee at your treating medical facilities. Due to participation in this study, patients may be asked to participate in future studies. Prior approval in the form of additional research protocols, however, will be obtained from the Human Subjects Protection Committee at your treating medical facilities, and patients will be required to sign separate informed consent forms for all such studies.
Risks. The risks of this protocol are minimal and are limited to complications of phlebotomy, such as discomfort from the needle stick, bruising, and rarely infection; and loss of privacy. Standard sterile technique will be used at all times in the collection of blood specimens. In addition, research records will be handled as carefully as possible to maintain patient confidentiality in accordance with the Federal Privacy Act. Upon arrival in the Mesothelioma National Data/Tissue Bank Laboratory, all medical records and specimens (serum, blood cells, and tissue samples) will be coded and given a unique identification number. Subsequently, the information and specimens will be handled in a blinded fashion in all research procedures. The identity of the patients will be permanently linked to the specimens only by a confidential log that will be maintained in a locked file by the principle investigator at UCLA/MARF, Dr. Robert B. Cameron. This research will be covered by an NIH-sponsored Certificate of Confidentiality.
Data Analysis
The primary method of data analysis will depend on the individual research study. Since most studies will include small numbers of specimens for analysis, it is anticipated that a nonparametric method of data comparison will be used.
Benefits
There sill be no direct benefit to patients participating in this study; however, it is hoped that the information gained form this study will help in the immunologic treatment of patients with thoracic malignancies in the future..
Consent
An informed consent (see addendum) will be signed by all patients entering this protocol. It will be obtained by one of the investigators at the time of initial outpatient consultation or upon inpatient admission for surgery.
Investigators
MARF Principle Investigator. Dr. Robert B. Cameron is a cardiothoracic surgeon and chief of general thoracic surgery and thoracic oncology at UCLA and the West Los Angeles VA Medical Center. He completed his medical school education at UCLA School of Medicine where he also completed his general surgery training. He completed addition training fellowships in surgical oncology at the National Cancer Institute under the auspices of Dr. Steven A Rosenberg and in cardiothoracic surgery at New York Hospital/Cornell Medical Center and Memorial Sloan-Kettering Cancer Center under Drs. O. Wayne Isom and Robert J. Ginsberg. He has extensive experience in cancer research with over 40 publications in this field.
MARF Executive Director. Chris Hahn earned undergraduate degrees summa cum laude in Philosophy and English, and is an Order of the Coif graduate of the Boalt Hall School of Law, University of California, Berkeley. His professional background includes extensive involvement in nonprofit law and administration as well as three years with the West Coast law firm of Heller, Ehrman, White & McAuliffe, and eight years with Seed, Mackall & Cole, one of the preeminent business law firms in Santa Barbara. Chris is a skilled communicator, organizer, problem solver, and advocate. He has served MARF as Executive Director since July, 2000.
UCLA Data Nurse. Rusela Bedrejo has over 10 years of nursing experience, including acute care (ICU and Medical/Surgical Unit care), case management, and utilization review. She will be solely responsible to the data entry and with Dr. Cameron will maintain the confidentiality of all patient information and specimens.
