MDACC Study Summary 2006-0856

Study Summary
No. 2006-0856:.......Skin......Michael R. Migden......Dermatology

Study Summary Title



Study Summary Number:	2006-0856

Study Title:	Spectral Diagnosis of Cutaneous Malignancy

Physician

New Patient Referral



Name:	Michael R. Migden	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Dermatology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-1450 Contact us about clinical trials

General Information



Disease Group:	Skin	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	n/a

Treatment Agents:	None	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to evaluate the use of an imaging technology called spectral diagnosis. Researchers want to find out if a special spectral-diagnosis probe can be used to detect skin cancers.

Study Objectives / Outcomes

The overall and primary objective of this device study is to develop improved methods for the noninvasive detection of cutaneous malignancies.

The specific objectives of this study are:

Primary:
1. Determine the spectroscopic features of skin lesions in vivo.
2. Develop the SD system to distinguish between normal, pre-malignant, and malignant skin lesions.

Secondary:
Determine the sensitivity and specificity of the SD system for the diagnosis of pigmented lesions.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	04/17/2007

Study Type:	Other

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) Male or Female and over 18 years of age.

2) Patients undergoing an examination of their skin

3) Patients with a lesion(s) in one of the five categories: basal cell carcinoma, squamous cell carcinoma, pre-cancer lesions, pigmented lesions, and benign lesions

4) Patients whose lesion also warrants a biopsy.

5) Signed informed consent document.

Exclusion Criteria:

1) Patients with absence of skin lesion(s) in one of the five categories.

2) Patients whose identified lesion did not need a biopsy.

3) Patients who did not sign the informed consent and agree to participate.

Links

Registration Number: NCT00476905
Study Information on Clinical Trials Registry (clinicaltrials.gov)