Pilot Study of Thrombophilic states in Newly Diagnosed Patients with High-grade Gliomas
Protocol Version: July 7, 2005
| Purpose of Study | Eligibility Criteria | Treatment Schedule | Sample Informed Consent | Patient Information |
The overall objective of this study is to assess the thrombophilic states in adult patients with high-grade gliomas (a supratentorial grade III or IV astrocytoma: anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma multiforme) undergoing anti-neoplastic therapy.
Primary Objectives
To estimate an overall hazard rate of first venous thromboembolism per person-year of follow-up in adult patients with high-grade gliomas undergoing anti-neoplastic therapy.
To assess the association between ABO blood type and venous thromboembolism in adult patients with high-grade gliomas undergoing anti-neoplastic therapy.
To assess the association between factor VIII level and the venous thromboembolism in adult patients with high-grade gliomas undergoing anti-neoplastic therapy.
Secondary Objectives
To estimate an overall incidence rate and the individual incidence rate of thromboembolism among various blood types.
To assess the association of other clinical variables such as type of anti-neoplastic treatments, KPS status, type of tumor, and the association with demographic factors such as age with venous thromboembolism in adult patients with high-grade gliomas undergoing anti-neoplastic therapy.
Inclusion Criteria
1. Patients must be at least 18 years of age.
2. Patients must have histologically confirmed malignant brain tumor by pathology. A supratentorial grade III or IV astrocytoma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma multiforme).
3. Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy) or hormonal therapy for their brain tumor. Glucocorticoid therapy and Gliadel is allowed.
4. Patients must have a Karnofsky performance status ³ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
5. Patients must be able to provide written informed consent.
6. Patients must identify a caregiver to provide patient information if the patient becomes unable to remember or communicate information during their course of therapy.
Exclusion Criteria
Patients with any of the following are ineligible for this research study:
Patients with a history of prior cranial irradiation.
Patients who have had a prior thrombotic event.
Patients receiving chronic anticoagulation.
One hundred and seven consecutive patients with newly diagnosed high-grade astrocytomas who will undergo anti-neoplastic therapy will constitute the study population. Patients participating in this study will sign consent and be registered with the NABTT Central Office. Pre-study information including demographic information and performance status will be obtained. A blood sample will be collected at this time. This blood sample will be used to determine the patient’s factor VIII and C reactive protein levels. Instructions for collecting and shipping blood specimen are found in section 9.0. If there is no documentation available stating the patient’s blood type, it may be necessary to collect an extra blood sample in order to determine patient’s blood type.
The patient’s registration date will be considered the patient’s start date. Every month (q 28 days beginning from the start date) the following data will be collected:
Ø KPS
Ø Treatment information (what treatment, duration of the treatment, etc.)
Ø Information regarding thrombotic events (PE or DVT, date, etc.)
This information may be collected over the phone by a nurse or during a clinic visit with the patient. All patients will be followed monthly in this manner until the patient experiences a thrombotic event. Patients will be followed every 2 months for survival from the time of a thrombotic event until death.
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 should the patient be unable to remember or communicate this information during the monthly evaluation (visit or phone call).
This is a clinical trial, a type of research study. Your study doctor will explain the clinical trial to you. Clinical trials include only patients who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor for more explanation.
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 (anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme).
Some patients with brain tumors develop blood clots called
pulmonary embolism (PE) or deep vein thrombosis (DVT). These blood clots can be
serious and life threatening. We believe different blood types (i.e. A, AB, B,
O) and the level of different blood proteins and clotting factors found in blood
may increase or decrease your risk of developing a blood clot. In this study we
hope to learn more about risks that may be associated with your blood type.
Participation in this study will in no way affect the therapies and/or
medications you can receive for treatment of your brain tumor.
WHY IS THIS STUDY BEING DONE?
The main purpose of this study is to learn if a patient’s blood type and
clotting factor levels are useful tools to determine a patient’s risk for
developing a blood clot.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
About 107 people will take part in the study.
WHAT IS INVOLVED IN THE STUDY?
Before joining this study your medical history will be reviewed. A nurse will
ask you if you have any inherited conditions that predispose you to blood clot
formation. Blood will be drawn to determine your factor VIII level and
C-reactive protein levels. It is likely that your blood type has already been
determined and should be located in your medical records. If there is no
documention of your blood type you may need to have blood drawn at this time to
determine your blood type.
In this study your information about brain tumor treatments and occurrences of blood clots will be monitored monthly. Every month a nurse will either call you on the phone or if you are coming to the clinic for a scheduled visit the nurse will see you in clinic. The nurse will ask you about the treatments you have received for your brain tumor. Your nurse will also ask you if you have had any blood clots. If you have experienced a blood clot you will be asked what kind of blood clot, the date of the blood clot, and what treatment you received for the blood clot. You do not need to return to this institution every month for these evaluations. These montly evaluations will stop if you have experienced a blood clot. If you have experienced a blood clot we will, however, continue to call you every 2 months to check on you.
Prior to beginning this study it is important for you to identify a caregiver. You will need to tell the nurse the name and contact information of someone who will be responsible for communicating the information specified above in the event that you are not able to remember all of the information or do not feel well enough to communicate it to the nurse.
With your permission we would like to save any blood or DNA that are left over after our testing is complete for future studies. If you agree to allow us to save plasma and DNA for these studies please indicate your agreement by checking the box provided below.
I agree to allow the investigators to save my plasma and DNA for future studies.
I do not agree to allow the investigators to save my plasma and DNA for future studies.
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 study doctor and your regular doctor first
HOW LONG WILL I BE IN THE STUDY?
We would like to keep track of your medical condition for the rest of your life. Every month we want to call you and check to see if you have had a blood clot. If you have a blood clot we will stop calling every month. If you have a blood clot we will call you every 2 months to see how you are doing. If you do not have a blood clot we will continue to call you on a monthly basis.
CAN I STOP BEING IN THE STUDY?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop.
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.
ARE THERE ANY BENEFITS TO TAKING PART IN THIS STUDY?
If you agree to take part in this study, there is no direct medical benefit to you. You will not receive any therapy as part of this research study. We want to find out if information about a patient’s blood type or blood protein levels will help us take better care of patients with brain tumors. If we are able to determine when the risk of a blood clot is greatest we may learn how to better treat patients at a greater risk. We hope the information learned from this study will benefit other patients with brain tumors in the future.
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 ARE THE COSTS?
The factor VIII and C reactive protein testing will be performed free of charge.
If it is necessary to perform a blood test to determine your blood type you or
your insurance company will be responsible for this blood test. You or your
insurance company will be responsible for 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 be paid for taking part in this research 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:
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.
i. 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. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from this institution.
We will tell you about new information that may affect your health, welfare or willingness to stay in this study.
In the case of injury resulting from this study, you do no lose any of your legal rights to seek payment by signing this form.