Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386906
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2006-10-10
Brief Title:
Sentinel Lymph Node SLN Biopsy for ConjunctivalEyelid Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 clinical research study is to find the sentinel lymph node SLN s and biopsy it them to see if the patient has small or low volume metastatic disease that would otherwise have been missed
Detailed Description:
You have had your conjunctival or eyelid tumor surgically removed or it is scheduled to have it removed You will have lymphatic mapping before the tumor is removed Lymphatic mapping is when a small volume of Tc99m-Sulfur colloid is injected by an ophthalmologist after which some radiologic images are taken
If you are able to become pregnant blood about 2 teaspoons will be drawn for a pregnancy test within 7 days before the biopsy To take part in this study you must not be pregnant
You will then go to the operating room and have intraoperative SLN mapping and biopsy If the SLN is positive on permanent section you will go on to have complete lymph node dissection which involves removal of all the lymph nodes around the positive SLN Then the disease will be restaged and you may require further treatment after consultation with their oncologist
Your medical record will be reviewed and information from your medical record will be recorded and reviewed to help researchers better identify those patients who have microscopic lymph node disease The information collected from your medical records will include information about your sex age what type of cancer that you have as well as the size of the cancer and its location
Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious With this technique researchers could potentially identify occult metastatic disease which would otherwise go unnoticed until it was too advanced Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup which is routine for conjunctivaleyelid melanoma
Length of Study
Your active participation on this study will be over once the biopsy is over You will continue to be observed on study for 5 years after the biopsy
Long-Term Follow-Up
Every 3 months for the first year after the biopsy and every 6 months after that until 5 years after the biopsy you will have an eye exam to check the status of the disease
Every 6 months for the first year after the biopsy blood less than 1 teaspoon will be drawn for liver function tests You will also have a chest x-ray You will then have these tests 1 time each year for 5 years after the biopsy
You will have a head and neck CT or MRI every 6 months for the first year after the biopsy to make sure the disease has not come back The head and neck CT or MRI will be repeated 1 time each year for 5 years after the biopsy
This is an investigational study A total of 38 patients will take part in this study All will be enrolled at MD Anderson Cancer Center
If you are able to become pregnant blood about 2 teaspoons will be drawn for a pregnancy test within 7 days before the biopsy To take part in this study you must not be pregnant
You will then go to the operating room and have intraoperative SLN mapping and biopsy If the SLN is positive on permanent section you will go on to have complete lymph node dissection which involves removal of all the lymph nodes around the positive SLN Then the disease will be restaged and you may require further treatment after consultation with their oncologist
Your medical record will be reviewed and information from your medical record will be recorded and reviewed to help researchers better identify those patients who have microscopic lymph node disease The information collected from your medical records will include information about your sex age what type of cancer that you have as well as the size of the cancer and its location
Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious With this technique researchers could potentially identify occult metastatic disease which would otherwise go unnoticed until it was too advanced Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup which is routine for conjunctivaleyelid melanoma
Length of Study
Your active participation on this study will be over once the biopsy is over You will continue to be observed on study for 5 years after the biopsy
Long-Term Follow-Up
Every 3 months for the first year after the biopsy and every 6 months after that until 5 years after the biopsy you will have an eye exam to check the status of the disease
Every 6 months for the first year after the biopsy blood less than 1 teaspoon will be drawn for liver function tests You will also have a chest x-ray You will then have these tests 1 time each year for 5 years after the biopsy
You will have a head and neck CT or MRI every 6 months for the first year after the biopsy to make sure the disease has not come back The head and neck CT or MRI will be repeated 1 time each year for 5 years after the biopsy
This is an investigational study A total of 38 patients will take part in this study All will be enrolled at MD Anderson Cancer Center
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01480 | REGISTRY | NCI CTRP | None |