Blood and Tumor Sample Collection From Patients With Malignant Melanoma for Long Term Storage
Researchers at M. D. Anderson want to learn as much as possible about melanoma and other
cancers. One way researchers can learn more about cancer is by studying what is in your
blood and in your tumor.
If you agree to take part in this study, the way you participate will depend on if you are
being treated for cancer. If you are receiving any form of chemotherapy, you will have about
4 1/2 tablespoons of blood drawn before you start the first day of treatment. You will then
have about 3 tablespoons of blood drawn every 6 to 8 weeks for the next 6 months. You will
have a total of up to about 5 blood draws for this portion of the study. You will have the
above blood draws during routine visits so that no additional visits will be required.
If you are receiving "immunologic or targeted" cancer treatment, you will have blood drawn
for testing. Immunologic treatment is a kind of treatment which boosts your immune system
to fight your cancer. Targeted cancer treatment is a kind of treatment which disrupts the
functions of proteins that are needed for tumor growth. About 4 1/2 tablespoons of blood
drawn before you start the first day of treatment. You will then have about 3 tablespoons
of blood drawn 1 time during the first 2 weeks (Days 2-14), 1 time during the second 2
weeks (Days 15-28), 1 time during second or third month (Days 29 - 90), and then once every
3 months for up to 5 years. A total of no more than 25 samples will be drawn.
After the 6-month period, if follow-up is scheduled for you at M. D. Anderson, you will have
about 3 tablespoons of blood drawn (during the follow-up visits) once every 3 months for the
next 5 years. You will have a total of 20 blood draws for this portion of the study. During
your follow-up, you will have a routine clinic visit to monitor any tumor recurrences
(occurring again). You will continue to have this visit about every 2 to 6 months, depending
on the risk of any tumor recurrence.
If you are not receiving any form of cancer treatment, you will have about 4 1/2 tablespoons
of blood drawn on the day that you enroll in this study. If you agree (it is your choice) to
participate in the follow-up portion of this study, you will have about 3 tablespoons of
blood drawn (during the follow-up visits) once every 3 months for the next 5 years. You will
have a total of about 21 blood draws for this portion of the study.
If you do not agree to take part in the additional follow-up, your participation in this
study will be over.
If you are planning to have surgery to remove your tumor as part of your standard care, some
of your tumor samples will be collected at that time and stored in a secure and confidential
laboratory at M. D. Anderson. If the tumor samples are too small, the whole tumor sample
will be sent to a doctor for a diagnostic evaluation. If this is the case, researchers will
not use any of your tumor sample for this study.
If you have tumors like skin lesions or lymph node lesions that are located close to the
skin, and you plan to have cancer treatment, a sample of your tumor will be collected before
you receive your cancer treatment. It will also be collected up to 2 other times (for this
study's research), while you are on treatment. A total number of biopsy will not exceed 6
per year, and will not exceed more than 10 over 5 year period. The biopsies will be
performed by using a small needle (with or without an ultrasound imaging machine), a punch
knife, or a small surgery. If you have tumors located close to the skin but do not plan to
receive cancer treatment, you will be asked to have a tumor biopsy up to 2 times per year
for up to 5 years.
Before your blood and tumor samples can be used for research, the people doing the research
must get specific approval from the institutional review board (IRB) of M. D. Anderson. The
IRB is a committee made up of doctors, researchers, and members of the community. The IRB
is responsible for protecting the participants involved in research studies and making sure
all research is done in a safe and ethical manner. All research done at M. D. Anderson,
including research involving your blood and/or tumor samples from this bank, must first be
approved by the IRB.
This is an investigational study. Up to 200 patients will take part in this study. All
will be enrolled at M. D. Anderson.
Observational Model: Case-Only, Time Perspective: Prospective
Collection and long-term collection of blood and tumor samples from patients with malignant melanoma for future biological and/or surrogate marker studies.
Kevin B. Kim, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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