Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation with Magnetic Resonance Imaging Findings
Protocol Version: July 11, 2005
| Purpose of Study | Eligibility Criteria | Treatment Schedule | Sample Informed Consent | Patient Information |
To estimate the correlation between changes in the quantity of serum tumor-specific DNA in the serum over time and concurrent changes in brain tumor size as determined by serial MRI or CT scans in patients with malignant glioma.
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 have a Karnofsky performance status ³ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
4. Patients must be able to provide written informed consent.
Exclusion Criteria
There are no exclusion criteria for this study.
Sixty consecutive patients with newly diagnosed or recurrent high-grade astrocytomas who will undergo anti-neoplastic therapy on NABTT protocol 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 for DNA analysis and an MRI will be collected at this time. If the patient is unable to undergo MRI, CT scans will be performed consistently and used for tumor analysis.
Note: patients who do not demonstrate tumor-specific DNA in their plasma will have their total plasma DNA concentration measured at enrollment and followed only for survival.
Every 2 months (beginning from the time the patient is registered for this study) the following data will be collected:
Ø KPS
Ø Blood sample for DNA analysis
Ø MRI/CT scan
Ø Treatment Information (what treatment, duration of treatment, etc.)
The MRI that will be collected every 2 months will be part of standard of care. Patients will need to return to the clinic every 2 months so that blood can be drawn and a nurse can collect information regarding treatments the patient has received for their brain tumor. Often, it will be possible to obtain the blood specimen during routine blood draws for tests unrelated to this proposed study. This will minimize the number venipunctures required.
Due to the specific nature of the information collected from the patient every 2 months, it will be very important for patients enrolled on this study to have a strong support system. The patient should 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 the necessary information during the bi-monthly evaluation.
All patients will be followed every 2 months in this manner until death. Patients who are clinically declining may not be able to undergo the required observations. If a physician feels a patient is clinically unable to comply with required follow up then the patient’s condition and inability to comply with protocol should be documented on the Follow-up/Treatment Form. Patients in this condition, or who demonstrate no tumor-specific DNA in their blood, will be followed every 2 months only for survival.
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 a
glioma.
WHY IS THIS STUDY BEING DONE?
There is special DNA (the chemical that makes up our genes) in each tumor. This
DNA can tell us what special defects are in the genes of your tumor. Many
tumors send their DNA into the blood. This research study is being done to see
if there is tumor DNA in your blood. If there is, we want to know if it tells
us anything about your tumor and how it behaves. Tumor DNA in the blood can be
collected with a routine blood draw and then tested. We know that we can detect
the special defects in the genes of your tumor with a very sensitive test called
PCR. We know that these defects may change within one person’s tumor over
time. We don’t know if the changes in these defects will predict changes in the
type of tumor or its size. In this research study we would like to look at the
gene defects found in the DNA in your blood and see how they change over time.
We would like to compare the changes in your blood to the changes seen in your
tumor by using a brain scan. The information we collect from this research
study will help us better understand brain tumors and how we can better treat
them.
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
About 60 people will take part in the study.
WHAT IS INVOLVED IN THE STUDY?
Before joining this study your medical history will be reviewed and blood will
be drawn for a DNA analysis. An MRI of your brain will also be obtained. These
evaluations will be repeated every other month. You will need to return to this
institution every other month for these evaluations. The MRI that is obtained
is part of your standard care. There is nothing experimental about the MRI.
The blood collected for this study is for research purposes only and would not
be collected if you were not participating in this study.
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.
The research that is done with your DNA is not designed to specifically help you. It might help people who have cancer in the future.
Reports about research done with your DNA will not be given to you or your doctor. These reports will not be put in your health record. The research will not have an effect on your care.
Things to think about: The choice to let us keep your DNA for future research is up to you. No matter what you decide to do, it will not affect your care. If you decide now that your DNA can be kept for research, you can change your mind at any time. Just contact us and let us know that you do not want us to use your DNA. Your DNA will no longer be used for research. In the future, people who do research may need to know more about your health. While the “researcher” may give them reports about your health, it will not give them your name, address, phone number or any other personal information that will let the researchers know who you are. Your DNA will be used only for research and will not be sold. The research done with your DNA may help to develop new products in the future.
Benefits: The benefits of research using DNA include learning more about how to treat cancer.
Risks: The greatest risk to you is the release of information from your health records. We will do our best to make sure your personal information will be kept private. The chance that this information will be given to someone else is very small.
Making your choice: Please read each sentence below and think about your choice. After reading each sentence, circle “Yes” or “No”. If you have any questions, please talk to your doctor or nurse, or call our research review board at IRB’s phone number.
No matter what you decided to do, it will not affect your care.
YES NO
YES NO
YES NO
ARE THERE ANY BENEFITS TO TAKING PART 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. This research will help us take better care of patients with brain tumors. 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?
You will not be charged for the DNA analysis of your blood samples. You or your
insurance company will be responsible for other expected and unexpected costs
associated with this study. Your insurance company may cover routine health
costs such as MRI scans. 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 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.