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Skin Cancer clinical trials

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NCT ID: NCT00588315 Active, not recruiting - Skin Cancer Clinical Trials

In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

Start date: November 1999
Phase:
Study type: Observational

The purpose of this study is to investigate new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies. The High-resolution OCT (Apollo Medical Optics) device can provide both cross-sectional and en-face images with cellular information. Real-time color images through the same objective with OCT are also provided to show the OCT imaging location of lesion. The color image can be registered simultaneously on a larger dermoscopic image obtained by an external dermoscope. The imaging mode of cross-sectional, en-face and color image can be switched arbitrarily to align the lesion and obtain high-resolution images efficiently. The total imaging time is around 10 to 15 minutes depending on the number of images to be obtained. To help identify more diagnostic features of optical imaging and better understand their histology correlation, we have developed a novel technique called "precision biopsy". Precision biopsy is an optical imaging guided, feature-targeted mini-biopsy. Once the feature of interest is identified and isolated by the optical imaging, a 2.0 mm punch biopsy is performed. Besides cosmetic benefit of minimal scarring, this tissue sparing biopsy captures the "feature of interest" for histology revelation. Additionally, the histologic features of precision biopsy will be compared to images gathered by multi-modal optical imaging. The precision biopsy will also be compared to the traditional shave biopsy or shave excision, to determine whether the diagnostic information is comparable between the two methods. For live remote control (LRC) imaging consultation, MSK dermatologist will based on his clinical examination. An imaging technician will perform the clinical and dermoscopic imaging, while the expert reader will perform confocal imaging remotely via a HIPPA compliant Webex platform.

NCT ID: NCT00578214 Completed - Anxiety Clinical Trials

Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery

Start date: March 2007
Phase: N/A
Study type: Interventional

Midazolam is an approved sedative medication used for medical procedures. This study was being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in patients prior to undergoing Mohs micrographic surgery for the treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may make a patient relaxed and sleepy, and lower blood pressure. These effects last for about 2 hours. This study had two parts. In the first part, eligible patients were randomized to either receiving one standard dose of midazolam syrup or placebo syrup before their surgery, with neither the patient nor the study team knowing which patient received the study drug. In the second part, patients who were not eligible to participate in the randomized study or who refused to participate in the randomized study were enrolled in a prospective arm where they knew they were receiving midazolam syrup. In the prospective arm, the doses were based on the patient's weight, and patients were given additional doses of midazolam syrup as necessary to control their anxiety. The primary hypothesis of this study was that a single dose of oral midazolam syrup to patients prior undergoing outpatient Mohs micrographic surgery for skin cancer would result in lower anxiety scores at 60 minutes compared to placebo. In addition, the second hypothesis of this study was that patients given oral midazolam would have the rate of adverse events that was not worse than 25% higher than in the placebo group.

NCT ID: NCT00555633 Completed - Skin Cancer Clinical Trials

Use of an SPF30 Sunscreen and an After-sun-lotion in Skin Cancer Risk Patients

Start date: October 2004
Phase: N/A
Study type: Observational

Study aim: To determine the effect of an intensified daily photoprotection over 24 months with an SPF30 sunscreen and an after sun-lotion both containing liposomal DNA repair enzymes in a population of patients at high-risk for skin cancer, including xeroderma pigmentosum (XP) and basal cell nevus syndrome.

NCT ID: NCT00535769 Completed - Skin Cancer Clinical Trials

Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

Start date: September 2007
Phase: Phase 0
Study type: Interventional

The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows: 1. To determine whether the use of electronic reminder system increases adherence to topical agents. 2. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes. 3. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system. 4. To obtain subjects' feedback on the adherence monitoring and reminder system.

NCT ID: NCT00526032 Completed - Skin Cancer Clinical Trials

Melanoma Detection by Oblique-Incidence Optical Spectroscopy

Start date: September 2006
Phase: N/A
Study type: Observational

Primary Objectives: - To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the adjacent normal skin for self-referencing. The experimental database will contain demographic information, clinical diagnoses, clinical images, OIR images, histopathologic diagnoses, and morphometric data on the lesions. - To develop and validate a diagnostic algorithm: 1. Classification: A subset (~50%) of OIR images collected will be used to complete the development of state-of-the-art image processing algorithms to extract robustly effective diagnostic features. 2. Blind Testing and Evaluation: The algorithms established will be evaluated and validated in a prospective blind-test fashion using the complementary subset of the database that was not involved in designing the classifier. The sensitivity and specificity of the classification system will be evaluated based on the receiver-operating-characteristic (ROC) curve. - To identify the pathophysiologic parameters responsible for the diagnostic optical features: The anatomic and physiologic sources of the diagnostic optical signatures will be identified by comparative analyses using the OIR images, microscopic histomorphometric techniques and theoretical modeling to test the following hypotheses: 1. The calculated differences in hemoglobin oxygen saturation. 2. Comparisons of the calculated size distributions of skin scattering centers with histologic and morphometric analyses of various cellular and tissue components of the skin lesions. 3. The relative densities and distributions of the different anatomic and physiologic diagnostic features within the interrogation volumes are important diagnostic factors in OIR.

NCT ID: NCT00520299 Completed - Metastatic Melanoma Clinical Trials

Study of ADI-PEG 20 in Patients With Advanced Melanoma

Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at escalating doses weekly for 9 weeks (cycle 1) or 8 weeks (subsequent cycles). The primary objectives were to the establish the safety, tolerability, and clinical efficacy of ADI-PEG 20. Secondary objectives included evaluation of the metabolic activity by [18F]-fluorodeoxyglucose positron emission tomography (FDG PET), pharmacodynamics, correlation of immunogenicity with clinical response, and correlation of argininosuccinate synthetase (ASS) tumor expression with clinical response.

NCT ID: NCT00509496 Terminated - Melanoma Clinical Trials

Phase II Study of Metastatic Melanoma With Lymphodepleting Conditioning and Anti-gp100:154-162 TCR Gene Engineered Lymphocytes

Start date: June 2007
Phase: Phase 2
Study type: Interventional

Background: - Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type, human leukocyte antigen (HLA-A*0201) derived from the gp100 protein. A retroviral vector was constructed that can deliver the TCR to cells. - This gene-engineered cell is over 10 times more reactive with melanoma cells than is the melanoma antigen recognized by T-cells (MART-1) TCR that resulted in tumor shrinkage for two patients with metastatic melanoma. Objectives: - To determine whether an anti-melanoma protein receptor can be put in cells removed from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors. - To evaluate safety and effectiveness of the treatment. Eligibility: - Patients 18 years of age or older with metastatic cancer melanoma (cancer that has spread beyond the original site). - Patient's leukocyte antigen type is HLA-A*0201. Design: -Patients undergo the following procedures: - Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-gp100 protein is inserted into the cells using an inactivated (harmless) virus in a process called retroviral transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. - Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1 hour for 2 days to suppress the immune system so that the patient's immune cells do not interfere with the treatment. - Treatment with anti-gp100. Patients receive an IV infusion of the treated cells containing anti-gp100 protein, followed by infusions of a drug called IL-2 (aldesleukin), which helps boost the effectiveness of the treated white cells. - Patients are given support medications to prevent complications such as infections. - Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). - Patients are evaluated with laboratory tests and imaging tests, such as CT scans, 4 to 6 weeks after treatment and then once a month for 3 to 4 months to determine the response to treatment. - Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.

NCT ID: NCT00509288 Completed - Melanoma Clinical Trials

Phase II Study of Metastatic Melanoma With Lymphodepleting Conditioning and Infusion of Anti-MART-1 F5 TCR-Gene-Engineered Lymphocytes

Start date: June 2007
Phase: Phase 2
Study type: Interventional

Background: - Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type,HLA-A 0201 (human leukocyte antigen) derived from the gp100 protein. A retroviral vector was constructed that can deliver the T-cell receptor (TCR) to cells. - Patients' cells will be converted into cells able to recognize and fight melanoma tumors. Objectives: - To determine whether TCR-engineered lymphocytes can be put in cells removed from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors. - To evaluate safety and effectiveness of the treatment. Eligibility: - Patients 18 years of age or older with metastatic cancer melanoma (cancer that has spread beyond the original site). - Patient's leukocyte antigen type is HLA-A 0201. Design: -Patients undergo the following procedures: - Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-MART-1 protein is inserted into the cells using an inactivated (harmless) virus in a process called retroviral transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. - Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1 hour for 2 days to suppress the immune system so that the patient's immune cells do not interfere with the treatment. - Treatment with anti-melanoma antigen recognized by T-cells (MART)-1. Patients receive an intravenous (IV) infusion of the treated cells containing anti-MART-1 protein, followed by infusions of a drug called IL-2 (aldesleukin), which helps boost the effectiveness of the treated white cells. - Patients are given support medications to prevent complications such as infections. - Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). - Patients are evaluated with laboratory tests and imaging tests, such as CT (computed tomography) scans, 4 to 6 weeks after treatment and then once a month for 3 to 4 months to determine the response to treatment. - Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.

NCT ID: NCT00492895 Completed - Skin Cancer Clinical Trials

Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients

Start date: June 2007
Phase: Phase 4
Study type: Interventional

Photosensitivity of the skin to UVA and UVB will be determined

NCT ID: NCT00476905 Completed - Skin Cancer Clinical Trials

Spectral Diagnosis of Cutaneous Malignancy

Start date: April 2007
Phase:
Study type: Observational

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.