IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
Bone Marrow Analysis in Early-Stage Breast Cancer
What is a research study?
This is a clinical trial, a type of research study. Your study doctor will explain the clinical
trial to you. Clinical trials include only people 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.
Why have I been asked to take part in this research study?
You are being asked to take part in this study because you have early-stage breast
cancer. You will be having either a mastectomy or lumpectomy to remove the tumor in
your breast.
Who is conducting this study?
The National Surgical Adjuvant Breast and Bowel Project (NSABP) in conjunction with
the University of Vermont Medical Center is conducting this study.
(The NSABP institution must supply appropriate information as to who is
conducting the trial locally.)
Why is this research study being done?
The purpose of this study is to learn if finding cancer cells in the bone marrow has any
importance in predicting the time of survival after a diagnosis of breast cancer. Bone
marrow is the spongy tissue inside bones where blood cells are made. The importance
of finding cancer cells in the bone marrow is unknown at this time. We want to compare
how long patients with breast cancer live when they have cancer cells in the bone
marrow with how long patients with breast cancer live who do not have cancer cells in
the bone marrow. This study also will look at two different methods of finding cancer
cells in the bone marrow to determine if one is better than the other.
How many people will take part in the study?
About 1,634 women and men will take part in this study.
What will happen if I take part in this research study?
During the study. If you meet all the requirements to be in the study, and you choose to
take part, then you will have the following procedure:
At the time you are having your surgery to remove your breast cancer we would like to
collect some of your bone marrow. The bone marrow collection is called a bone marrow
aspiration. This involves putting a needle into each of your hip bones and taking out a
small amount of the bone marrow (approximately 1 - 2 teaspoons from each side). This
is done while you are under anesthesia for your surgery.
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Participant Initials _____
IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
Your surgeon will perform your breast surgery as planned. This study will not affect the
type of surgery you have or your regular cancer care.
The bone marrow sample will be sent to the University of Vermont Medical Center for
testing. Later in this consent form we will ask for your permission that any remaining
tissue from your bone marrow aspiration be allowed to be stored for future research.
Only after the results of the bone marrow study have been reviewed to meet the
purpose of this study will your sample be stored for future research. This will be
explained to you in detail at the end of this consent form.
How long will I be in the study?
You will be in the study for 10 years. Getting the bone marrow samples is only done
once during the study. The NSABP would like to keep track of you by contacting you or
your study doctor about once a year and asking how you are doing.
Can I stop being in the study?
Yes. You can decide to stop at any time. Even after your bone marrow aspiration, you
may request that no new information about you be reported to the NSABP. It is
important to tell the study doctor if you are thinking about stopping or decide to stop.
The study doctor may stop you from taking part in this study at any time if he/she
believes it is in your best interest or if the study is stopped.
What side effects or risks can I expect from being in the study?
The bone marrow aspiration in this study has risks and side effects. Most of them are
listed here, but they will vary from person to person. There may be other side effects
that we cannot predict. Most side effects from this study are mild and last for only a
short time but, in some cases, side effects can be serious, long-lasting or permanent.
You should talk to your study doctor about any side effects that you have while taking
part in the study.
Bone marrow aspirates can be collected from the front part of the hip bone or from the
back part of the hip bone. Your study doctor will talk with you about this.
Risks associated with bone marrow aspiration. The bone marrow aspiration will be
performed while you are asleep under anesthesia, and you will not feel the procedure.
When you wake up, it is common to have some minor discomfort that may feel like a
bruise around the area where the needle was inserted in each hip bone. There is a
small risk of infection and bleeding in the area where the needle was inserted in each
hip bone.
For more information about risks and side effects, ask your study doctor.
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Participant Initials _____
IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
Are there benefits to taking part in the study?
There will not be any direct medical benefit to you for taking part in this study. Because
at this time we do not know the importance of finding cancer cells in the bone marrow,
we will not tell you or your doctor the results of the testing done for this study.
The information learned from this study could help future cancer patients.
What other choices do I have if I do not take part in this study?
This study is not a treatment study; therefore, your medical care will be the same if you
choose to take part in this study or if you choose not to. If you choose not to take part,
your doctor will continue to give you the best care possible.
Will my medical information be kept private?
We will do our best to make sure that the personal information in your medical record
will be kept private. However, we cannot guarantee total privacy. Your personal
information may be given out if required by law. If information from this study is
published or presented at scientific meetings, your name and other personal information
will not be used.
A record of your progress will be kept in a confidential form at your hospital or doctor’s
office where you receive treatment. Organizations that may inspect and/or copy your
research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for
quality assurance, research, and data analysis include groups such as:
Southeast Cancer Control Consortium (SCCC) Operations Office
National Surgical Adjuvant Breast and Bowel Project (NSABP)
University of Vermont (which will be conducting certain parts of the study and
acting as a coordinating center for some parts of this study
National Cancer Institute (NCI) and its representatives
Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) at your hospital
Canadian Health Products and Food Branch (HPFB)
Possible other federal or state government agencies
If your record is used or given out for governmental purposes, it will be done under
conditions that will protect your privacy to the fullest extent possible consistent with laws
relating to public disclosure of information and law-enforcement responsibilities of the
agency. These agencies may review the research to see that it is being done safely
and correctly.
You authorize the use of clinical information contained in your records, but any
publication which includes such information or data shall not reveal your name, show
your picture or contain any other personally identifying information, except as otherwise
required by law.
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Participant Initials _____
IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
What are the costs of taking part in this study?
There will be no cost to you for taking part in this study. There are no costs to you
related to the bone marrow aspiration or the bone marrow aspiration procedure.
Because samples for this study will be done at the same time as your surgery, all
doctors’ and hospital costs related to your surgery will be charged to you or your health
insurance provider, the same as if you were not part of this study.
You will not be paid for taking part in this study.
What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, _________________________ if you feel
that you have been injured because of taking part in this study. You can tell the doctor
in person or call him/her at #____________________________.
You will get medical treatment if you are injured as a result of taking part in this study.
You and/or your health plan will be charged for this treatment. The study will not pay for
medical treatment. Although no funds or monies have been set aside to compensate
you in the event of injury or illness related to the study treatment or procedures, you do
not waive any of your legal rights for compensation by signing this form.
You or your insurance company will be charged for continuing medical care and/or
hospitalization.
What are my rights if I take part in this study?
Taking part in this study is voluntary. You may choose to take part, 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 or result in any penalty or loss of benefits to which you are
entitled.
Even after you agree to take part in this study, you may withdraw at any time. Before
you withdraw, you should talk to one of the researchers or nurses involved. This will
allow them to inform you of any medical problems that could result from stopping your
treatment. You can choose to withdraw one of two ways. In the first, you can stop your
study treatment, but still allow the study doctor to follow your care. In the second, you
can stop your study treatment and not have any further contact with the study staff.
Either way, there will be no penalty to you. Your decision will not affect your medical
treatment or your relationship with those treating you or with this institution. If you
withdraw from the study, you will still be offered all available care that suits your needs
and medical condition. You are free to seek care from a doctor of your choice at any
time.
We will tell you about new information that may affect your health, welfare or willingness
to stay in this study. You may be asked to sign another consent form in response to
new information.
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Participant Initials _____
IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
Who can answer my questions about the study?
For questions about the study or a research-related injury, contact your doctor,
_________________, at # _____________________. You may ask your doctor for
further information on the risks, benefits or alternative treatments.
For questions about your rights as a research participant, contact the
___________________ Institutional Review Board (which is a group of people at the
hospital in the community where you receive treatment who review the research to
protect your rights) at # ____________________ (the office of
__________________________).
Additional tests for the NSABP BP-59 study
The following section of the informed consent form is about additional research studies
that may be done with people who are taking part in the main study. You may take part
in these additional studies if you want to. You can still be part of the main study even if
you say “no” to taking part in these additional studies.
Consent for use of tissue for future research:
About using tissue for future research: The NSABP would like to keep some of the
tissue samples that may be remaining after the University of Vermont Medical Center
completes the testing done for the main study. If you agree, the tissue samples will be
kept and may be used in future research to learn more about cancer and other
diseases. The tissue samples will be given only to researchers approved by the
NSABP. Any research study using your samples must also be approved by an IRB. The
research that may be done with your tissue samples is not designed to specifically help
you. It might help people who have cancer and other diseases in the future. Reports
about research done with your samples will not be given to you or your doctor. These
reports will not be put in your health records. The research using your tissue samples
will not affect your care.
Things to think about: The choice to let the NSABP keep the tissue samples for future
research is up to you. No matter what you decide to do, it will not affect your care in this
study. If you decide now that your tissue samples can be kept for research, you can
change your mind at any time. Just contact your study doctor and let him or her know
that you do not want the NSABP to use your tissue samples and they will no longer be
used for research. Otherwise, they may be kept until they are used up, or until the
NSABP decides to destroy them.
In the future, people who do research with your tissue samples may need to know more
about your health. While the NSABP may give them reports about your health, they will
not give them your name, address, phone number, or any other information that will let
the researchers know who you are.
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Participant Initials _____
IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
Sometimes tissue samples are used for genetic research (about diseases that are
passed on in families). Even if your tissue samples are used for this kind of research,
the results will not be told to you and will not be put in your health records.
Your tissue samples will be used only for research and will not be sold. The research
done with your samples may help to develop new products in the future, but you will not
get paid.
Benefits and risks: The possible benefits of research from your tissue include learning
more about what causes cancer and other diseases, how to prevent them and how to
treat them. The greatest risk to you is the release of information from your health
records. The NSABP will protect your records so that your name, address, and phone
number will be kept private. The chance that this information will be given to someone
else is very small. There will be no cost to you for any tissue collected and stored by the
NSABP.
Reminder: Required collection of the bone marrow aspirate: The bone marrow
aspiration is required for participation in the BP-59 study. By signing this consent form,
you are agreeing to have the bone marrow aspiration performed in order to meet the
purpose of the study described earlier in this consent form.
Making your choice:
Please read each sentence below and think about your choice. After reading each
sentence, circle “yes” or “no.” If you have questions, please talk to your doctor or
healthcare team member.
Participation in the optional use of your remaining bone marrow aspirate sample:
Remember, no matter what you decide to do about the storage and use of your tissue
samples, you may still take part in the BP-59 study.
1.
My tissue samples may be kept by the NSABP for use in future research to learn
about, prevent, or treat cancer.
YES
2.
NO
My tissue samples may be kept by the NSABP for future research to learn about,
prevent, or treat other health problems (for example: diabetes, Alzheimer's
disease, or heart disease).
YES
NO
Contact in the future for other research: Remember, no matter what you decide, you
may still take part in the BP-59 study.
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Participant Initials _____
IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
3.
My study doctor (or someone he or she chooses) may contact me in the future to
ask me to take part in more research.
YES
NO
Where can I get more information?
 You may call the National Cancer Institute’s (NCI’s) Cancer Information Service
at:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615





You may also visit the NCI Web site at http://cancer.gov
For the NCI’s clinical trials information, go to: http://cancer.gov/clinicaltrials
For the NCI’s general information about cancer, go to:
http://cancer.gov/cancerinfo
Cancer Fax includes NCI information about cancer treatment, screening,
prevention, and supportive care. To obtain a contents list, dial 301-402-5874 or
800-624-2511 from a fax machine hand set and follow the recorded instructions.
You may also visit the NSABP Web site at http://www.nsabp.pitt.edu
Participant Contract
I have been offered the opportunity to ask questions about this study and all questions
have been answered to my satisfaction. The contents of this form have been explained
to me and I understand them. I agree to allow the research personnel specified above
the access to my medical records.
It may be necessary for my doctor to contact me at a future date regarding new
information about the treatment I received; therefore I agree to notify my doctor of any
change of address and/or telephone number.
My signature below means that I have voluntarily agreed to participate in this research
study. I will be given a copy of all 8 pages of this consent. I have read it or it has been
read to me. I may also request a copy of the study (complete study plan).
______________
(Date)
11/8/06
_________________________________
(Participant Signature)
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IRB Approval __________
Version Date: 11/8/06
APPENDIX A
NSABP BP-59
Southeast Cancer Control Consortium Consent Form
I certify that I have explained to the above individual the nature and purpose, the
potential benefits, and possible risks associated with participation in the research study
and have answered any questions that have been raised.
______________
(Date)
11/8/06
_________________________________
(Signature of Person Obtaining Consent)
Page 8 of 8
Participant Initials _____
NSABP BP-59
Southeast Cancer Control Consortium Withdrawal of Consent
I, _____________________________, withdraw my consent to participate in this study
and refuse to be followed and have clinical data collected from my medical records.
Participant Name ___________________________________ Study/ID #___________
(Please Print Name)
Participant Signature ____________________________________ Date ___________
Witness Signature ______________________________________ Date ___________
11/8/06
NSABP BP-59
Southeast Cancer Control Consortium Withdrawal of Treatment Consent
I, _____________________________, withdraw my consent for treatment on this study.
Even though I withdraw my consent for treatment, I will continue to be followed and
clinical data will be collected from my medical records.
Participant Name ___________________________________Study/ID #____________
(Please Print Name)
Participant Signature ____________________________________
Date __________
Witness Signature ______________________________________
Date __________
11/8/06