Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Nevus, Pigmented

Nevus

Melanoma

Nevi and Melanomas

Neoplasms by Histologic Type

Subjects with Nevi who will as part of their standard of care, will undergo biopsy.

Application of reagents, then imaging and scoring

Skin Fluorescent Imaging

BRANDI DUNN

Cathy Shachaf

Anchal Dhawan

Sunil Dhawan, MD

Lawrence Osman, MD

Serena Mraz, MD

Doug Grossman, MD

Douglas Grossman, MD

Cathy Shachaf, PhD

The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.

The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.

If the Site specific pathology lab will not allow the sponsor to make a digital image of the original slide, then the Sponsor is asking that a duplicate slide be provided for digital scanning. Once scanning is complete these additional slides may not be returned to the site.

Skin Fluorescent Imaging (SFI) System in Patients With Nevi

Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.

Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist

Adverse events will be collected to ensure overall safety of reagents and imaging

Orlucent, Inc

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Herpes Simplex

Keratosis, Actinic

Keratosis

Carcinoma, Basal Cell

Herpes Zoster

Skin Neoplasms

Warts

Tinea

Molluscum Contagiosum

Erysipelas

Impetigo

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Skin Diseases

Precancerous Conditions

Neoplasms, Basal Cell

Communicable Diseases

Virus Diseases

Chickenpox

Varicella Zoster Virus Infection

Herpesviridae Infections

DNA Virus Infections

Cellulitis

Skin Diseases, Infectious

Staphylococcal Skin Infections

Staphylococcal Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Streptococcal Infections

Skin Diseases, Bacterial

Poxviridae Infections

Skin Diseases, Viral

Neuroendocrine Tumor

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

This arm includes all subjects randomized to regular dermatological follow-up visits on annual basis.

This arm includes all subjects randomized to the use of a tele-dermatology system for the evaluation of newly onset non-widespread skin lesions.

The screening visit consists in a general dermatological examination of the subject, with special focus on the onset of the following skin diseases during the follow-up period:

1. bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
2. fungal skin infections (tinea corporis, cruris, pedis);
3. pigmented tumors (melanoma);
4. non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).

Screening

The system consists in a simple web-based/smartphone application through which subjects can send pictures of recently onset non-widespread skin lesions with special focus on the following diseases:

1. bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
2. fungal skin infections (tinea corporis, cruris, pedis);
3. pigmented tumors (melanoma);
4. non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).

A dermatology will judge online pictures based on a standard scale. Each subject who will use the system will be also seen by routine clinical visit to confirm the online diagnosis. Subjects who will not send any picture will be seen for a dermatological examination at the end of each year.

Tele-dermatology

Luigi Naldi, MD

The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.

Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo

Tele-dermatology of Skin Cancer: a Randomized Trial Comparing Remote Assessment With Conventional Visits in a Cohort of Local Health Authority Employees in the Province of Bergamo (the Shoot the Mole Study)

Centro Studi Gised

Subject with suspicious Nevi undergoing biopsy per SOC

Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy

Diagnostic Test

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

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin. SFI analyzes the topical staining of the skin surface using the ORL-1 dye to reveal the presence of remodeling in the skin, together with the visible feature characteristics. The system provides a biometric score corresponding to the dye staining, a structural score, and a composite SFI score to quantify the presence of tissue remodeling and the process of melanocytic transition in the skin.

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

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

To identify histological features that correlate with the imaging features captured using SFI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Skin Fluorescent Imaging (SFI) System in Patients With Nevi	NCT04368247	Nevus Dysplasia; Epit...	Skin Fluorescen...	18 Years -	Orlucent, Inc
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo	NCT02902822	Erysipelas Impetigo Herpes Zoster Molluscum Conta... Warts Tinea Melanoma Actinic Keratos... Basal Cell Carc... Squamous Cell C...	Screening Tele-dermatolog...	18 Years - 99 Years	Centro Studi Gised
Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)	NCT03535077	Skin Lesion Melanoma (Skin) Mole	Diagnostic Test	21 Years -	Orlucent, Inc
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo	NCT02902822	Erysipelas Impetigo Herpes Zoster Molluscum Conta... Warts Tinea Melanoma Actinic Keratos... Basal Cell Carc... Squamous Cell C...	Screening Tele-dermatolog...	18 Years - 99 Years	Centro Studi Gised

Spots Global Cancer Trial Database for mole

Every month we try and update this database with for mole 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 mole

Every month we try and update this database with for mole 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 mole 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.