Treatment Trials

23 Clinical Trials for Various Conditions

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COMPLETED
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma
Description

This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.

TERMINATED
Optical Coherence Tomography of Retinal Abnormalities Associated With Choroidal Nevus, Choroidal Melanoma and Choroidal Melanoma Treated With Iodine-125 Brachytherapy
Description

During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on consented subjects. The OCT is a new type of camera that takes very detailed pictures inside of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular tumors may lead to improved diagnosis and monitoring of tumors within the eye.

Conditions
UNKNOWN
BAP1 Testing in Instance Choroidal Nevi or Uveal Melanoma
Description

The BAP1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal melanoma for a germline BAP1 mutation and other genetic markers associated with developing malignancy as well as additional sequencing of the uveal melanoma genome.

COMPLETED
Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi
Description

A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.

Conditions
RECRUITING
Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
Description

This is an observational, non-therapeutic study to collect clinical and molecular information of pediatric patients with childhood melanocytic lesions. PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions (including melanoma, spitzoid melanoma, congenital melanoma, melanoma arising in giant nevi). SECONDARY OBJECTIVE: To collect minimal information on patients treated with adjuvant or systemic therapies according to National Comprehensive Cancer Network (NCCN) guidelines.

Conditions
RECRUITING
Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi
Description

This study will examine the impact of anti-programmed cell death 1 (PD1) therapy given in the approved adjuvant therapeutic regimens upon the morphologic, histopathologic, molecular and immunologic as well as genomic features of atypical/dysplastic nevi (A/DN) in patients with a prior documented melanoma of Stages IIB, IIC, IIIA, IIIB, or IIIC and concurrent presence of two or more atypical nevi.

Conditions
RECRUITING
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Description

The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.

COMPLETED
Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
Description

A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria.

COMPLETED
Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)
Description

This study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. The adjuvants that will be used in this trial are a CD40 antibody (CDX-1140) and a toll-like receptor (TLR) 3 agonist (Poly-ICLC). The study will also investigate the effects of the vaccine and the adjuvants on the immune response. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and skin tissue.

COMPLETED
Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma
Description

This trial studies an internet-based intervention for skin self-examination (SSE) in participants at increased risk for melanoma. Early detection of suspicious growths on the skin can be done by performing regular SSE checks. Using an internet-based intervention, such as mySmartCheck, may help to promote regular, thorough checks on the skin in individuals at increased risk for melanoma.

RECRUITING
MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma
Description

This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.

COMPLETED
Training Primary Care Physicians to Perform Melanoma Opportunistic Surveillance
Description

This is a four-phase educational intervention for primary care practitioners (PCPs) to perform opportunistic melanoma surveillance. Based on prior research, the investigator will develop an interactive melanoma early detection skills training program for PCPs according to the principals of mastery learning. The proposed educational intervention will improve practicing PCPs' knowledge, competence, confidence, and diagnostic performance regarding pigmented lesions and attitude concerning importance of skin surveillance. In addition, this research aims to examine the clinical proficiency of PCPs regarding pigmented lesions. The proposed educational intervention will reduce the percentage of benign lesions referred to dermatology.

COMPLETED
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Description

This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.

COMPLETED
Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions
Description

This is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.

COMPLETED
Natural History Study of Moles and Suspicious Melanoma
Description

Background: * Melanocytic nevi, or "moles," are non-cancerous growths of a type of skin cell called a melanocyte. * Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to grow before birth and is larger than moles that develop after birth. * Determining how melanocytes in moles and LCMNs differ from normal melanocytes may increase the ability to predict whether a mole will give rise to a melanoma (a type of skin cancer) Objectives: * To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin lesions that are suspicious for melanoma * To develop better criteria for diagnosing melanoma, particularly by using a device called a digital dermatoscope (a special camera, connected to a computer, that takes pictures of moles when they are magnified and illuminated) Eligibility: * Children 5 years old or older with an LCMN * Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at least one 4 mm or more * Adults 18 years old or older with a pigmented lesion suspicious for melanoma Design: * Patients' personal and family health history is obtained. * Patients are examined by investigative team doctors, and several lesions are examined with a dermatoscope. * Additional photographs of part or all of the skin surface may be taken. * Some lesions may be biopsied. * Additional tests or examinations may be recommended. * Patients are followed periodically for skin or physical examinations, photography, laboratory and imaging evaluations, and possible skin biopsies. * Children may undergo brain magnetic resonance imaging (MRI)

RECRUITING
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Description

This study will investigate how genetic and environmental factors contribute to the development of melanoma, a type of skin cancer, and related conditions. Individuals \>=4 weeks with a personal or family history of melanoma or atypical spitzoid/Spitz tumor may be eligible for this study. Participants will: * Fill out one or two questionnaires about their personal and family medical history. * Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with melanomas, tumors, cancer, or other related illnesses for whom they are the next-of-kin or legally authorized representative. * Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is collected through a needle in an arm vein. The cheek cell sample is obtained either by gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of mouthwash and then spitting it into a container.) * Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For this procedure, the area of skin to be removed is numbed with a local anesthetic and a 1/4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is then covered with a band-aid. Participants may be asked to travel to the NIH Clinical Center for evaluation, including a medical history, physical examination, and some of the following procedures: * Full body skin examination to evaluate the type and number of moles and document any evidence of sun damage to the skin. The examination involves all the skin from the scalp to the bottoms of the feet. After the examination, a medical photographer will photograph the skin, with close-ups of skin lesions marked by the examiner. If there are parts of the skin the participant does not want examined or photographed, he or she can tell the examiner. * Blood draw of about 120 milliliters (4 ounces) or less * Skin biopsy * Cheek cell sample * X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues. MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour. When the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up.

COMPLETED
Tretinoin With or Without Fenretinide in Treating Patients With Dysplastic Nevus Syndrome
Description

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of tretinoin and/or fenretinide may be an effective way to prevent the recurrence or further development of dysplastic nevus syndrome. PURPOSE: Randomized phase II trial to compare the effectiveness of tretinoin with or without fenretinide in treating patients with dysplastic nevus syndrome.

Conditions
COMPLETED
Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi
Description

Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin.

Conditions
TERMINATED
In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions
Description

This study aims to validate the use of laser in vivo confocal microscopy as an early diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection for early detection of tumor recurrence, and to evaluate the use of in vivo confocal microscopy in evaluation of response to treatment. The modified technique with Heidelberg Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in vivo as preliminary studies have shown.

COMPLETED
Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Description

This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

RECRUITING
Neurocutaneous Melanocytosis Registry
Description

This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).

COMPLETED
Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)
Description

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin

COMPLETED
Clinical and Histopathologic Characteristics of BAP1 Mutations
Description

The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.