CD4 Count and Risk Infection in Patients with Brain Tumors
Protocol Version: July 8, 2005
| Purpose of Study | Eligibility Criteria | Treatment Schedule | Sample Informed Consent | Patient Information |
Inclusion Criteria
Exclusion Criteria
One hundred consecutive patients with newly diagnosed high-grade astrocytomas who will undergo anti-neoplastic therapy will constitute the study population. Twenty-five patients with newly diagnosed low-grade astrocytomas who will not be treated with glucocorticoids or other anti-neoplastic agents will constitute the control group. Monthly CD4 counts and Heme-8 with differential will be collected to follow the serial CD4 counts in each patient for a period of one year. Data managers will fill out a CRF on a monthly basis, which has information about radiation treatment, dose of steroids, days of hospitalization, episodes of infection and CD4 count. It will be important to document patient’s start date and stop date of steroid administration. The dose of decadron will be rated as low, medium, and high for each month of collected information. This information may be collected over the phone by a nurse or during a nurse’s visit with the patient. A search of pathology specimen diagnosis for PCP pneumonia will be completed for each patient if an event of pneumonia or inpatient hospitalization occurs. Every effort will be made to determine the presence of opportunistic infections in patients who expire during the study. In addition, time points for start and end of therapy (i.e. radiation) will be collected. All patients will be followed for survival for one additional year (2 years total).
Due to the specific nature of the information collected from the patient each month, it will be very important for patients enrolled on this study to have a strong support system. The patient needs to appoint an available and able caregiver. The caregiver will be an additional source of patient information would the patient be unable to remember or communicate this information during the monthly evaluation (visit or phone call).
The goal of this study is to evaluate the trend of CD4 counts in patients with primary brain tumor. Serial CD4 counts will be quantitatively analyzed to determine if there is any particular treatment component or combination of components, which significantly reduces the CD4 level. A Heme-8 with differential will be collected monthly to evaluate if the patients are neutropenic. In addition, patients will fill out a questionnaire regarding any history or episodes of pneumonia or infection during the treatment of brain tumor.
CD4 Count and risk of infection in patients with brain tumors
This is a clinical trial (a type of research study). Clinical trials include only patients who choose to take part. Please take your time to make your decision. Discuss it with your friends and family.
This consent may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand.
You are being asked to take part in this study because you have been diagnosed with a brain tumor called an astrocytoma.
Some patients with brain tumors receive treatment with steroids to control brain swelling caused by the tumor. They may also receive radiation therapy or chemotherapy to treat the tumor. One of the side effects of these treatments is suppression of the immune system. If the immune system is suppressed, the patient is at greater risk of developing infections. The state of a part of the immune system can be monitored by a blood test called CD4.
Why is this Study Being Done?
The main purpose of this study is to learn if the CD4 count is a useful tool to monitor a patients risk for developing infections.
In this study your serial CD4 counts, complete blood counts and information about steroid dose and infections will be monitored monthly for one year.
Before joining this study your medical history will be reviewed and blood will be drawn for a complete blood count, a CD4 count, and a blood test to see if you are HIV positive.
HIV can cause acquired immunodeficiency syndrome (AIDS). If this blood test shows that you may have HIV you will not be able to participate in this study. Patients with HIV are excluded from this study because they have chronic low CD4 counts.
If you are not HIV positive your current steroid dose will be recorded and you will be questioned about infections and antibiotic use. These evaluations will be repeated monthly for one year. You do not need to return to this institution every month for these evaluations. The blood work may be done at a lab close to your home and the other information may be gathered through phone calls.
You can also stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first.
WHAT ARE THE POTENTIAL RISKS?
Drawing blood from your arm may cause pain, bruising, lightheadedness, and, on rare occasions, infection at the site of the needle puncture.
You will be told of any new information that may be discovered while you are participating in this study that might change your decision to be in this study.
If you agree to take part in this study, there may not be direct medical benefit to you. You will not receive any therapy as part of this research study. We want to find out if monitoring the CD4 count will help us take better care of patients with brain tumors. If we are able to determine when the risk of infection is greatest we may learn when it would be helpful to give the patient antibiotics. We hope the information learned from this study will benefit other patients with brain tumors in the future.
WHAT ARE THE COSTS?
The cost of the required blood tests for 12 months on this study will be approximately $3000. You or your insurance company will be responsible for this and any other unexpected costs associated with this study. You will be responsible for any costs not paid by your insurance. You may wish to check with your insurance company to find out what will be covered by your policy.
You will not receive cash or other gifts for taking part in this research study.
WHAT OTHER OPTIONS ARE THERE?
You do not have to join this research study. You may continue to get care from your physician even if you do not take part in the study.
WHAT ABOUT CONFIDENTIALITY?
This section tells you what information about you may be used and given out in this study and who may give and receive the information. By signing this consent form, you agree that health information that identifies you may be used and/or given out as needed in this study. _________________ has a policy to protect health information that may identify you. Federal and state laws also protect your privacy. ______________________ has procedures in place to support these policies and laws.
a. What information about you may be used or given out in this study?
Information that identifies you and relates to your health or medical condition may be used or given out in this study. Information that identifies you can include your name, address, telephone number, date of birth, Social Security number and other details about you. Information that relates to your health or medical condition includes:
Information obtained from the activities and procedures outlined in this consent form, which may include:
i) things done to see if you can join this study, such as physical examinations, blood and urine tests and any other information that you share with us, including information about your health history and your family health history; and
ii) information obtained during the study, such as how you respond to the study activities or procedures, information we learn in study visits, phone calls, surveys, physical examinations, blood and urine tests, x-rays and other tests and any other medical information we learn from you as a participant in this study.
b. Who may use and give out information about you?
Some people may see your health information and may give out your health information during this study. These include the researcher and the research staff, the institutional review boards and their staff, legal counsel, audit and compliance staff, officers of the organization and other people who need to see the information to help this study or make sure it is being done as it should.
c. Who may see your health information?
Other organizations may see your health information during this study. These include:
Governmental entities that have the right to see or review your health information, such as the Office of Human Research Protections and the Food and Drug Administration
NABTT (New Approaches to Brain Tumor Therapy) CNS Consortium and doctors and staff at other NABTT institutions that are participating in this study
The sponsor of this study and people that the sponsor my contract with for this study. The name of the sponsor is CTEP/NCI (Cancer Evaluation Therapy Program/National Cancer Institute. The Contract Research Organization is Theradex
The Data Safety Monitoring Board
An outside institutional review board
d. Why will this information be used and given out?
Your information will be used and given out to carry out this study and to evaluate the results of this study.
e. What if you decide not to give your permission to use and give out your health information?
You do not have to give your permission to use or give out your health information. However, if you do not give permission, you may not participate in this study.
f. May you withdraw or cancel your permission?
You may cancel your agreement to allow your health information to be used or given out at any time by sending a written notice to the Institutional Review Board Office, __________________________________. If you do this, you are leaving this study. If you leave this study, no new health information about you will be gathered after that date. However, information gathered before that date may be used or given out if it is needed for this study or any follow-up for this study.
g. Is your health information protected after it has been given to others?
If your health information is given to someone not covered by these policies and laws, that information may no longer be protected, and may be used or given out without your permission.
h. Does this consent form have an end date?
This authorization to use and give out health information continues until the end of this study and any necessary data analysis follow-up activities for this study.
A) What is the role of the IRB?
Research studies involving human volunteers are reviewed by an Institutional Review Board (IRB). The IRB is made up of doctors, nurses, scientists, non-scientists and people from the community. The IRB is responsible for protecting participant’s rights.
WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. We will tell you about new information that may affect your health, welfare or willingness to stay in this study.
WHO DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or a research-related injury, contact _________________ at ____________________.
For questions about your rights as a research participant, contact the _______________ Institutional Review Board (which is a group of people who review the research to protect your rights) at _________________.
WHERE CAN I GET MORE INFORMATION?
You many call the NCI’s Cancer Information Service at
1-800-4 Cancer (1-800-422-6237) or TTY: 1-800-332-8615
Visit the NCI's Web sites
i cancerTrials: comprehensive clinical trials information
http://cancertrials.nci.nih.gov
iCancerNet: accurate cancer information including PDQ
http://cancernet.nci.nih.gov