Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00507325 |
| Other study ID # |
2005-0466 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 13, 2006 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this laboratory research study is to collect blood and tumor samples from
patients with malignant melanoma. Researchers want to store these samples in a secure and
confidential laboratory at M. D. Anderson. Researchers will use the information that is
learned in this study to help find ways to improve treatment for melanoma and other cancers.
Description:
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.
