MDACC Study Summary GSP00-106

Study Summary
No. GSP00-106:.......Eye......Bita Esmaeli......Ophthalmology/Head & Neck Surgery

Study Summary Title



Study Summary Number:	GSP00-106

Study Title:	Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma

Physician

New Patient Referral



Name:	Bita Esmaeli	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Ophthalmology/Head & Neck Surgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6920 Contact us about clinical trials

General Information



Disease Group:	Eye	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	At least every three months during the first year, every 6 months during the 2-5th year, and as needed.

Treatment Agents:	Biopsy Lymphatic Mapping	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	There is no hospital stay. Patients will be treated in outpatient basis and released on the same day.


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary Objectives:
a) Identify the rate of SLN positivity in conjunctival/eyelid melanomas.
b) 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.

Study Status Information



Study Activation / Registration Date:	05/30/2000

IRB Review and Approval Date:	03/23/2000

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Participants must be 18 years of age or older.

2) Histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness, or those less than 1 mm thick that have evidence of ulceration, mitotic figures or are Clark IV.

3) A CXR, liver enzymes, and a head and neck comptuted tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis.

4) Participant must have a negative ultrasound of regional lymph nodes (i.e., within 6 weeks of study enrollment).

5) Patient provided written informed consent. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC Policy for Consenting Non-English Speaking Participants.

Exclusion Criteria:

1) Pregnant or nursing females.

Links

Registration Number: NCT00386906
Study Information on Clinical Trials Registry (clinicaltrials.gov)