Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid

You are being asked to take part in this study because you have eyelid sebaceous gland carcinoma (cancer of the eyelid) and have had or are scheduled to have the tumor(s) removed. The goal of this clinical research study is to use sentinel lymph node (SLN - the lymph nodes closest to the primary tumor that are believed to be at greatest risk for spread of the disease) mapping to find SLNs and biopsy them to see if you have metastatic disease (cancer that has spread) that would otherwise have not been found.

Disease Group: Eye

Treatment Agent: None

Treatment Location: Only at MDACC

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

Sponsor: N/A

Return Visit: At least every 3 months (+/- 6 weeks) during the first year, every 6 months (+/- 6 weeks) during the 2-5th year, and as needed.

Home Care: N/A.

Primary Objectives: a) Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas. b) Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas. Secondary Objective: Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid.

IRB Review and Approval Date: 02/25/2009

Recruitment Status: Open

Projected Accrual: N/A

1) Participant must be 18 years of age or over.
2) Possible or suspicious sebaceous gland carcinoma of the eyelid.
3) A CXR (chest x-ray), liver enzymes, and a head and neck CT or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis.
4) 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.

1) Pregnant or nursing females.

713-794-1247

Phone Number: 800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

clinicaltrials.gov NCT No: NCT00832429

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