Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Skin Neoplasms

Melanoma, Cutaneous Malignant

Nevus, Pigmented

Nevus

Nevus, Epithelioid and Spindle Cell

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Diseases

Nevus, Spindle Cell

Neuroendocrine Tumor

Neuroepithelioma

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)

The objective of this study is to understand early transformation and malignant progression events of cutaneous melanoma by obtaining detailed clinical information and lesional tissue for analysis, cell culture, and immortalization from patients with melanocytic nevi, which frequently are precursor lesions of melanoma, and primary melanoma. An important goal of this study is the acquisition of melanocytes from lager congential melanocytic nevi (LCMN) and acquired melanocytic nevi (AMN) for analysis, culture and experimental manipulation. We do not propose to acquire melanocytes from pigmented lesions suspected to represent primary melanoma because of the importance of preserving all lesional tissue required to render accurate histopathological diagnosis. However, another aim of the study is the development of enhanced clinical criteria for the diagnosis of primary cutaneous melanoma, particularly using digital epiluminescent skin microscopy, or dermoscopy, for pigmented lesion image acquisition and analysis. The close comparison of dermoscopic images of pigmented skin lesions suspicious for melanoma with lesional histopathology should be useful for expanding the knowledge base about how dermoscopy , a relatively new technique used to evaluate pigmented skin lesions, can be used to diagnose a pigmented skin lesion as benign or malignant. These detailed comparisons may also provide information about how specific visual features within the dermoscopic image field correlate with histologic features of the lesion. This information may be useful for future possible studies designed to predict accurately which portions of a primary malignant melanoma can be removed for esperimental study while retaining sufficient lesional information to guide further treatment and render an accurate prognosis.

The study population will consist of three categories of patients: (1) infants and children with large congenital melanocytic nevi, (2) adults with numerous (less than 100) melanocytic nevi, and (3) patients with primary malignant melanoma. Establishment of the Pigmented Lesion Clinic required for the execution of this protocol will provide a mechanism for the evaluation of patients with numerous or unusual pigmented lesions, and for the entry of eligible patients into ongoing therapeutic trials for malignant melanoma. As the study progresses, it is anticipated that a substantial amount of formalin-fixed nevus and primary melanoma tissue with a high-degree of clinical annotation will be collected. As a secondary objective , the availability of this collection will be useful to support studies designed to evaluate new markers and techniques for the diagnosis of melanoma and atypical nevi, and for incorporation into a tissue microarray that will be available to the melanoma research community for target foundation validation.

Background:

The molecular events resulting in melanocyte transformation and the development of early melanoma are incompletely understood. Risk factors for the development of melanoma include genetic, phenotypic and environmental risk factors and can overlap. Also, persons with large numbers of nevi face a higher risk of melanoma. These risk associations, combined with knowledge obtained from basic studies on the survival, differentiation, and proliferation of the melanocyte, can provide hints about the molecular mechanisms that underlie the development of nevi and melanoma.

In this study we plan to acquire lesional tissue from pigmented lesions and develop enhanced clinical criteria for the diagnosis of primary cutaneous melanoma, particularly using digital epiluminescent skin microscopy, or dermoscopy, for pigmented lesion image acquisition and analysis. This information may be useful for future possible studies designed to predict accurately which portions of a primary malignant melanoma can be removed for experimental study while retaining sufficient lesional information to guide further treatment and render an accurate prognosis.

Objectives:

To obtain tissue from benign melanocytic nevi and from large congenital melanocytic nevi (LCMN) for experimental study.

To refine culture and immortalization methods for melanocytes derived from melanocytic nevi, permitting in vitro expansion of these cells for functional study.

To correlate clinical and dermoscopic observations of primary melanomas with histopathology to establish standards for sampling primary melanomas in a possible future study.

Eligibility:

Infants/Children less than 5 years of age with large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp.

Adults greater than 18 years of age with greater than 100 melanocytic nevi greater than 2 mm in diameter with at least one melanocytic nevus greater than 4 mm in longest dimension or with a current pigmented lesion clinically suspicious for primary melanoma.

Design:

This is a natural history protocol designed to enroll 110 subjects who will be evaluated and followed over the course of their disease.

Natural History Study of Moles and Suspicious Melanoma

Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma

National Cancer Institute (NCI)

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Syndrome

Melanosis

Pigmentation Disorders

Dysplastic Nevus Syndrome

Nevus, Blue

Hyperplasia

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Hyperpigmentation

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Anesthetics

Formaldehyde

Only data from medical records and formalin-fixed paraffin-embedded tissue blocks will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio

Only data from medical records, formalin-fixed paraffin-embedded tissue blocks and cytologic slides will be collected from patients in this cohort. Patients with skin or mucosal melanoma and dysplastic nevi which have been already excised are eligible. FFPE tissue blocks with MPATH-Dx Class 1-2 vs Class 3-5 will be collected in approximately 1:1 ratio

Patients with pigmented lesions on the skin or mucosa who are referred for excisional biopsy will be offered to apply investigated non-invasive adhesive system on their lesion just before the excisional biopsy. After biopsy cytological slides and FFPE tissue blocks will be prepared. All three types of obtained samples will be investigated separately (adhesive patches, cytologic slides and FFPE tissue blocks) for genetic markers whereas cytologic slides and FFPE tissue blocks will be processed also routinely and regular cytologic and histopathologic report will be generated.

The already registered on the market adhesive skin patch will be applied and removed for several times on the pigmented skin (or mucosal) lesion just before the preplanned excisional biopsy after local anaesthesia have been already administered. Excisional biopsy and local anaesthesia are not the part of this study and will be carried out according to local practice

Non-invasive adhesive system (patch)

Igor V Samoylenko, MD, PhD

Lev V Demidov, MD, PhD

Oxana E Garanina, MD, PhD

Irena L Shlivko, MD, PhD, DSc

Igor Samoylenko, MD, PhD

Kirill Baryshnikov, MD, PhD

Kristina V Orlova, MD, PhD

This is a multicenter, ambispective, low-interventional clinical study evaluating molecular genetic markers for non-invasive differential diagnosis of benign and malignant pigmented skin and mucosal neoplasms. In retrospective cohorts genetics markers will be identified. In prospective cohort non-invasive adhesive system will be tested to identify malignant or benign lesions with prespecified sensitivity and specificity compared to other non-invasive techniques (i.e. dermoscopy) and using histopathological examination as a "golden standard".

Ambispective study with two retrospective cohorts and one prospective cohort

Atypical MOLes and Melanoma Early Detection Study (MoleMed)

A Multicenter, Ambispective, Low-interventional Clinical Study Evaluating Molecular Genetic Markers for Non-invasive Differential Diagnosis of Benign and Malignant Pigmented Skin and Mucosal Neoplasms

•Assessment of the sensitivity and specificity of a complex of molecular genetic studies applicable for non-invasive differential diagnosis of benign and malignant melanocytic neoplasms of the skin and mucous membranes in comparison with a standard histological examination

Assessment of the sensitivity, specificity, positive and negative prognostic significance of the developed molecular genetic method for non-invasive differential diagnosis of benign and malignant pigmented neoplasms of the skin and mucous membranes in comparison with clinical diagnosis with an naked eye by an oncologist or dermatologist

Blokhin's Russian Cancer Research Center

Russian Academy of Medical Sciences

Principal Investigator, Senior Researcher, Department of Oncodermatology, MD, PhD

Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy

Optical Spectroscopy

David JB Hsiang, MD

Bruce Tromberg, PhD

The incidence of malignant melanoma has increased dramatically in recent decades. In 1930, the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500. This has been exponentially increasing over the years with the risk estimated to be 1 in 75 in 2000 . According to the American Cancer Society, approximately 59,580 new cases of melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected to die of the disease.

The researcher ucan use special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. The imaging devices are, Modified Two Layer Diffuse Optical Spectroscopy,multi-spectral imaging, and Spatially Modulated Quantitative Spectroscopy can use to measure atypical moles and melanoma and correlate the results of the biopsy tissue histology.

The imaging devices can quantify melanin, oxy and deoxy hemoglobin concentration, water, lipid and reduced scattering coefficients and can compare results to histopathologic. Atypical moles and melanoma have a different optical profile based on physiological parameters compared to benign nevus.

A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions

A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters

Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology

Beckman Laser Institute University of California Irvine

University of California, Irvine

David Hsiang, M.D., Division of Surgical Oncology

All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histo-pathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.

LIMES

Claus Garbe, MD

All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.

FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA)

A Prospective, Non-controlled, Multicenter Clinical Study to Evaluate the Diagnostic Accuracy of the Stepwise Two Photon Excited Melanin Fluorescence of Potentially Malignant Pigmented Lesions as Compared to Histopathological Diagnosis

The comparator and gold standard for the diagnosis will be the histopathological diagnosis of the pigmented lesions.

University Hospital Heidelberg

Charite University, Berlin, Germany

University Hospital Tuebingen

Subjects with moles suspicious of melanoma and are scheduled for an urgent excision.

Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision.

Melanoma Detection System -MDS

The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).

The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.

Investigating the Clinical Utility of the MDS

Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma

To gain feedback from users on how to best incorporate the MDS testing procedure in the clinical setting.

The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation.

Does the MDS system provide superior results when compared to clinical evaluation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Natural History Study of Moles and Suspicious Melanoma	NCT00288938	Melanocytic Nev... Acquired Melano... Primary Cutaneo...		5 Years -	National Institutes of Health Clinical Center (CC)
Atypical MOLes and Melanoma Early Detection Study (MoleMed)	NCT04353050	Melanoma Melanoma (Skin) Moles Nevus Nevus, Blue Nevus, Pigmente... Nevus, Spitz Nevi, Spindle C... Nevi, Dysplasti... Dysplastic Nevu... Mucosal Melanom... Mucosal Melanos...	Non-invasive ad...	18 Years -	Russian Academy of Medical Sciences
A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions	NCT00633516	Skin Cancer	Optical Spectro...	18 Years -	University of California, Irvine
A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions	NCT00633516	Skin Cancer	Optical Spectro...	18 Years -	University of California, Irvine
FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA)	NCT02425475	Melanoma Moles	LIMES	18 Years -	University Hospital Tuebingen
Investigating the Clinical Utility of the MDS	NCT03109327	Skin Lesion Melanoma Moles	Melanoma Detect...	18 Years - 99 Years	Orlucent, Inc
Natural History Study of Moles and Suspicious Melanoma	NCT00288938	Melanocytic Nev... Acquired Melano... Primary Cutaneo...		5 Years -	National Institutes of Health Clinical Center (CC)
Atypical MOLes and Melanoma Early Detection Study (MoleMed)	NCT04353050	Melanoma Melanoma (Skin) Moles Nevus Nevus, Blue Nevus, Pigmente... Nevus, Spitz Nevi, Spindle C... Nevi, Dysplasti... Dysplastic Nevu... Mucosal Melanom... Mucosal Melanos...	Non-invasive ad...	18 Years -	Russian Academy of Medical Sciences
Natural History Study of Moles and Suspicious Melanoma	NCT00288938	Melanocytic Nev... Acquired Melano... Primary Cutaneo...		5 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for moles

Every month we try and update this database with for moles cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for moles

Every month we try and update this database with for moles cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for moles cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.