Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Nevus, Pigmented

Nevus

Skin Diseases

This is a single-arm prospective trial. Participants perform self-skin exams using naked-eye criteria and will take smartphone clinical images (SCI) of each PSL of concern (PSLC). Participants will also take digital dermoscopy images (DDIs) and apply the Sklip System (integrating the Sklip Mole Scan Algorithm (SMSA) to each PSLC of concern in up to 14 days. Within up to 28 days of completing the at-home exams, participants will undergo an in-office visit full body skin exam (FBSE).

Dermoscopy

Digital Photography

Self-Skin Examination

Skin Examination with Sklip

Undergo in-person full body skin examination (FBSE)

Skin Examination

Survey Administration

Sancy A. Leachman, MD, PhD

Khoa Nguyen

This is a new protocol to analyze how the use of the Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for the detection of PSLCs that require biopsy (Melanoma and atypical melanocytic nevi with uncertain malignant, Squamous cell carcinoma, Basal cell carcinoma).

The study protocol will also compare the accuracy of the Sklip System when used by a layperson (Participant) versus near-perfect Sklip System user (Study Coordinator), assess whether Sklip System improves triage of PSLCs \< 6 mm in diameter and triage of thin melanomas with \<0.8 mm Breslow depth as suspicious, as compared to the current medical provider virtual triage method that relies on store-and-forward of smartphone clinical images (SCI), and assess accuracy of layperson-performed self-skin-exams (SSEs) at-home in the identification of all suspicious PSLCs present on their body as compared to the same layperson (Participant) evaluated with a full body skin examination (FBSE) by a dermatology Provider (DP) in-person.

PRIMARY OBJECTIVE:

I. The Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals\* for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is recommended in the pathologist management comment) (≥95% sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity).

EXPLORATORY OBJECTIVES:

I. To compare the accuracy of Sklip System triage when used by a layperson versus near-perfect Sklip System user II. To assess whether Sklip System improves triage of pigmented skin lesions of concern \< 6mm in diameter as suspicious as compared to the current medical provider virtual triage method that relies on store-and-forward non-medical-device assisted smartphone clinical images III. To assess whether Sklip System improves triage of thin melanomas with \< 0.8 mm Breslow depth as suspicious as compared to the current medical provider virtual triage method that relies on store-and-forward non-medical-device assisted smartphone clinical images IV. To determine the accuracy of layperson-performed self-skin-exam(s) at-home in the identification of all suspicious pigmented skin lesions of concern present on their body as compared to the same layperson evaluated with full body skin examination by a dermatology Provider in-office

OUTLINE:

This is a single-arm prospective trial. Participants perform self-skin exams using naked-eye criteria and will take smartphone clinical images (SCI) of each PSL of concern (PSLC). Participants will also take digital dermoscopy images (DDIs) and apply the Sklip System to each PSLC of concern in up to 14 days. Within up to 28 days of completing the at-home exams, participants will undergo an in-office visit full body skin exam (FBSE).

At-Home Dermoscopy Artificial Intelligence

At-Home Dermoscopy Artificial Intelligence for Optimizing Early Triage of Skin Cancers and Atypical Melanocytic Nevi With Uncertain Malignant Potential

To analyze layperson Sklip System triage of self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is recommended in the pathologist management comment) (≥95% sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity). Two-sided 95% confidence intervals for all Sensitivities and Specificities will be calculated using the Exact (Clopper-Pearson) method.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Breast Neoplasms

Photographs og consecutive group of 346 patients operated with breast conserving surgery were used to investigate cosmetic outcomes.

Photographs og consecutive group of 30 patients operated with DIEP-flap were used to assess cosmetic results

Photographies with digital cameras were taken postoperatively for the documentation, anonymised and used for evaluation of cosmetic results after surgery.

digital photography

This paper will present a specific tool for evaluation of cosmetic results after breast conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap. Introduction of a breast score system using digital photography seems to be a reliable tool for estimation of cosmetic results after breast surgery. The method has been employed on a specific group of 346 consecutive patients operated for breast cancer with breast conserving surgery. For the purpose of this study breast score system was tested on patients with free flap breast reconstruction (DIEP flap).

Background: Validated instruments for assessing results after breast surgery are sparse. Investigators want to present a method used for the past 10 years at their institution for evaluation of the outcome after breast conserving surgery (BCS) and microsurgical breast reconstruction. Methods: 346 consecutive patients subjected to BCS for cancer and 30 patients operated with a deep inferior epigastric flap (DIEP ) were assessed at least one year after the operation. The Telemark Breast Score is a method based on standard two-dimensional photographs assessing the outcome after breast surgery in terms of volume, shape and symmetry. Three different panels including plastic surgeons, breast surgeons and nurses were invited to test the Telemark Breast Score. Consistency of agreement between and inside the panel groups was studied Results: Inter- and intra observer reliability was acceptable. Good stability of ratings could be shown in test-retests.

Conclusion: The Telemark Breast Scale is inexpensive, statistically reliable and can be applied for quality control after breast surgery.

The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery

The Telemark Breast Score is a Valid Method for the Evaluation of Outcome After Reconstructive Surgery of the Breast

Sykehuset Telemark

overlege

Symptoms and General Pathology

Carcinoma

Neoplasm Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.

Digital photographs taken of array placement

Lumbar Puncture

Magnetic Resonance Imaging

Transducer arrays applied and wear NovoTTF-200T

Medical Device Usage and Evaluation

Clinical Trials Referral Office

Kurt A. Jaeckle, M.D.

Kurt A Jaeckle, M.D.

This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.

PRIMARY OBJECTIVE:

I. To evaluate the safety and feasibility of TTFields in treatment of the spinal component of leptomeningeal metastases.

SECONDARY OBJECTIVE:

I. To document any preliminary signals of activity, as measured by radiographic and clinical response, or durable stability of objective neurologic examination, utilizing Leptomeningeal Assessment in Neuro-Oncology (LANO) criteria, magnetic resonance imaging (MRI) imaging, cerebrospinal fluid (CSF) cytologic examination, and patient-reported symptom assessment (M. D. Anderson Symptom Inventory \[MDASI\]-spine module).

OUTLINE:

Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo lumbar puncture (LP) during screening and on study.

Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast Cancer

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine

Will be measured by grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management. (i.e. grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Cancer Therapy Evaluation Program Active Version Common Terminology Criteria for Adverse Events.

Will be estimated the number of patients who are unable to complete at least 30 days of TTF therapy (a composite average for the 30 days of at least 50% of array 'on' time) divided by the total number of evaluable patients.

Descriptive analyses will be performed. Data evaluated will include: cerebral spinal fluid (CSF) cytologic response; magnetic resonance imaging radiographic response within the TTF field.

Descriptive analyses will be performed. Data evaluated will include: Time to CSF cytologic response (defined as the date of initiation of TTF to the last date of three consecutive negative CSF cytologic examinations).

Descriptive analyses will be performed. Data evaluated will include: Duration of cytologic response (time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology).

Descriptive analyses will be performed. Data evaluated will include: Neurologic progression-free survival; duration of TTF treatment; overall survival from start of TTF.

Mayo Clinic

Immune System Diseases

Blood and Lymph Conditions

Rare Diseases

Graft vs Host Disease

Hematologic Neoplasms

Hematologic Diseases

Chronic Graft Versus Host Disease

Homologous Wasting Disease

Patients undergo collection of tears, saliva, buccal mucosa, and fecal samples before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also undergo collection of blood samples before stem cell transplant, at 1-2, 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients may undergo skin and mouth biopsy over 15-30 minutes before stem cell transplant, at 2-3 and 12 months after stem cell transplant, and at cGVHD onset. Patients undergo digital pictures of the eyes, mouth and skin, and optical coherence tomography before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients without standard of care formal pulmonary function test undergo portable spirometry at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also complete surveys and have their medical records reviewed.

Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples

Biospecimen Collection

Optical Coherence Tomography

Spirometry

Quality-of-Life Assessment

Medical Chart Review

Marcie Hall

Steven Pavletic

Stephanie Lee

This trial observes and collects samples from patients before and after stem cell transplantation to learn more about how and why a complication called chronic graft-versus-host disease (GVHD) develops after stem cell transplantation. Performing close observation and various types of testing may enable doctors to notice symptoms or problems sooner than they would normally have been noticed and predict which patients will develop chronic GVHD.

OUTLINE:

Patients undergo collection of tears, saliva, buccal mucosa, and fecal samples before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also undergo collection of blood samples before stem cell transplant, at 1-2, 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients may undergo skin and mouth biopsy over 15-30 minutes before stem cell transplant, at 2-3 and 12 months after stem cell transplant, and at cGVHD onset. Patients undergo digital pictures of the eyes, mouth and skin, and optical coherence tomographybefore stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients without standard of care formal pulmonary function test undergo portable spirometry at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also complete surveys and have their medical records reviewed.

After completion of study, patients are followed up periodically.

Blood, tissue, saliva, tears, buccal mucosa, feces

Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study

Close Assessment and Testing for Chronic GVHD (The CATCH Study)

Will compare the pg/ml levels and trajectories of proteins (IL-1b; IL-4; IL-5; IL-6; IL-8; IL-10; IL-13; IL-17a (pg/mL); TNF; G-CSF; IFNgamma; MCP-1; IL-12p40; GM-CSF; IL-2) between patients who do and do not develop chronic graft versus host disease (cGVHD). Blood will be analyzed separately from saliva and conjunctival washings.

Onset of cGVHD will be treated as a time-to-event endpoint, using Cox regression with monthly levels or slopes of the markers entered as time dependent covariates.

Will compare the levels, proportions and trajectories of different cellular populations between those with and without cGVHD, and with different cGVHD organ involvement and symptoms. The following cell subtypes are of highest interest: Th17, FOXP3+ T regulatory cells, FOXP3- T regulatory type 1 (TR1) cells, T follicular helper cells, activated B cells, B regulatory cells, and monocytes but the list may evolve before actual testing.

Tissue alterations will be classified into Abnormal and Normal, and measured by biopsy and/or advanced bioimaging techniques. Histologic findings, ribonucleic acid (RNA) expression profiles, optical coherence tomography (OCT) findings and digital image interpretations will be compared between patients who do and do not develop cGVHD or who have different cGVHD clinical phenotypes and symptoms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
At-Home Dermoscopy Artificial Intelligence	NCT05321784	Malignant Skin ...	Dermoscopy Digital Photogr... Self-Skin Exami... Skin Examinatio... Skin Examinatio... Survey Administ...	21 Years -	OHSU Knight Cancer Institute
The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery	NCT02853227	Breast Cancer	digital photogr...	-	Sykehuset Telemark
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast Cancer	NCT05746325	Anatomic Stage ... Metastatic Brea... Metastatic Mali...	Digital Photogr... Lumbar Puncture Magnetic Resona... Medical Device ...	18 Years -	Mayo Clinic
At-Home Dermoscopy Artificial Intelligence	NCT05321784	Malignant Skin ...	Dermoscopy Digital Photogr... Self-Skin Exami... Skin Examinatio... Skin Examinatio... Survey Administ...	21 Years -	OHSU Knight Cancer Institute
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast Cancer	NCT05746325	Anatomic Stage ... Metastatic Brea... Metastatic Mali...	Digital Photogr... Lumbar Puncture Magnetic Resona... Medical Device ...	18 Years -	Mayo Clinic
Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study	NCT04188912	Hematopoietic a...	Biospecimen Col... Optical Coheren... Spirometry Survey Administ... Digital Photogr... Quality-of-Life... Medical Chart R...	18 Years -	Fred Hutchinson Cancer Center

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