Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid - Tabular View

Tracking Information

First Received Date ^ICMJE

October 10, 2006

Last Updated Date

October 6, 2009

Start Date ^ICMJE

May 2000

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Patients with SLN Positivity in Conjunctival/eyelid Melanomas [ Time Frame: Ophthalmologic exam to check for recurrence every three months during Year 1 and every 6 months during Years 2-5. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Identify the rate of SLN positivity in patients with conjunctival/eyelid melanoma. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00386906 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Identify the false negative rate of SLN biopsy in patients with conjunctival/eyelid melanoma. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid

Official Title ^ICMJE

Sentinel Lymph Node Localization and Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid: A Pilot Study

Brief Summary

The goal of this clinical research study is to localize 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.

Primary Objectives:

Identify the rate of sentinel lymph node (SLN) positivity in conjunctival/eyelid melanomas
Determine the false negative rate for SLN biopsy for the same

Secondary Objective:

Determine the complication rate for this technique, particularly with respect to local ocular and periocular side effects as well as the risk of facial nerve damage

Detailed Description

Patients in this study have had their conjunctival or eyelid tumor surgically removed or is scheduled to have it removed. Patients will have lymphatic mapping before their 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.

Patients will then go to the operating room and undergo intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, patients 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 patients may require further treatment after consultation with their oncologist.

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 conjunctival/eyelid melanoma.

This is an investigational study. A total of 38 patients will take part in this study. All will be enrolled at M.D. Anderson Cancer Center.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment

Condition ^ICMJE

Eye Disease
Melanoma

Intervention ^ICMJE

Procedure: Sentinel Lymph Node Mapping and Biopsy

Study Arms / Comparison Groups

Other: SLN = Sentinel Lymph Node

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participants must be 18 years of age or older.
Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness
Ability to undergo surgery under general anesthesia
A chest X-ray (CXR), liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis
Participants must have a negative ultrasound of regional lymph nodes.
Capable of giving written informed consent
Women of childbearing potential are not eligible unless tested negative for pregnancy prior to SLN mapping and biopsy.

Exclusion Criteria: N/A

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bita Esmaeli, MD

713-792-6920

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00386906

Responsible Party

Bita Esmaeli, MD/Assoc. Professor, U.T. M.D. Anderson Cancer Center

Study ID Numbers ^ICMJE

GSP00-106

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Bita Esmaeli, MD

U.T.M.D. Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP