MDACC Study Summary 2008-0266

Study Summary
No. 2008-0266:.......Eye......Bita Esmaeli......Ophthalmology/Head & Neck Surgery

Study Summary Title



Study Summary Number:	2008-0266

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

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 II	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.

Treatment Agents:	None	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 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.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	02/25/2009

IRB Review and Approval Date:	02/25/2009

Study Type:	Phase Ii Or Phase I/Ii

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) 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.

Exclusion Criteria:

1) Pregnant or nursing females.

Links

Registration Number: NCT00832429
Study Information on Clinical Trials Registry (clinicaltrials.gov)