Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507325
Status:
TERMINATED
Last Update Posted:
2022-09-02
First Post:
2007-07-24
Brief Title:
Sample Collection From Melanoma Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Blood and Tumor Sample Collection From Patients With Malignant Melanoma for Long Term Storage
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 12 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 12 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 12 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 studys 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 andor 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
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 12 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 12 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 12 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 studys 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None