Collection of CLINICAL DATA, Serum, Blood cells, and tissue samples from
patients with biopsy-proven or suspected MESOTHELIOMAS
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,
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.
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
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
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.
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..
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.
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.