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Skin Neoplasms clinical trials

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NCT ID: NCT05136196 Recruiting - Melanoma Clinical Trials

BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

Start date: December 6, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.

NCT ID: NCT05136079 Not yet recruiting - Clinical trials for Malignant Skin Neoplasm

Prophylactic LYMphatic Reconstruction (LYMbR) to Prevent Lymphedema After Node Dissection for Cutaneous Malignancies

LYMbR
Start date: January 2022
Phase: Phase 3
Study type: Interventional

Background: Lymphedema following lymph node dissection is a chronic condition that can limit physical, occupational, and social participation, impact self-image, and result in financial burden. Studies have reported lymphedema incidence rates of 39% to 73% following node dissection. Lymphaticovenous anastomosis (LVA) has been previously used to treat established lymphedema. More recently, with imaging capabilities guided by blue dye and indocyanine green dye, the possibility of prophylactic LVA has become feasible. A 2018 systematic review of 12 studies utilizing prophylactic LVA during lymphadenectomy indicated a 2/3 reduction in the risk of lymphedema. The literature yet lacks any phase III studies with stringent controls and long term follow-up. Objectives: To assess (primary endpoint) the impact of prophylactic LVA on presence or absence of lymphedema post axillary or groin lymphadenectomy and participant quality of life. To assess (secondary endpoint) the incidence of complications related to nodal dissection. Methods: This is a phase III RCT, block randomized for upper and lower extremities, recruiting adult patients planned for an axillary or groin node dissection as a result of cutaneous malignancy. Analysis of rates of lymphedema and quality of life reports will be done. Significance: Lymphedema is a feared outcome of surgical cancer care. Its impact on patients' daily lives is profound. A reduction of incidence of this debilitating condition by 2/3 would have significant impact on numerous lives and could also reduce the health system resources needed for its management.

NCT ID: NCT05135052 Recruiting - Clinical trials for Non-melanoma Skin Cancer

Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer.

EPIC-Skin
Start date: January 17, 2022
Phase: N/A
Study type: Interventional

Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study.

NCT ID: NCT05102773 Completed - Clinical trials for Clinical Stage IV Cutaneous Melanoma AJCC v8

The Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma Patients

Start date: February 10, 2020
Phase:
Study type: Observational

This pilot trial studies the effect of the microbiome on immune checkpoint inhibitors response in patients with melanoma by collecting stool and blood samples. Gut microbiome plays a critical role in response to immune checkpoint inhibitors. Studying the change in an individual's microbiome due to corticosteroid use may help researchers to determine whether an individual's microbiome can predict their response and toxicity to immune checkpoint inhibitors.

NCT ID: NCT05098210 Recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor Positive Her2 Negative Metastatic Refractory Breast Cancer

Start date: June 9, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma or hormone receptor positive Her2 negative breast cancer that has spread to other places in the body (metastatic) or does not respond to treatment (refractory). Personalized neo-antigen peptide vaccine is a product combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.

NCT ID: NCT05087485 Completed - Melanoma Clinical Trials

Integrated Basic Science Within the Instructional Design of Pattern Recognition Training

AISC-ISF
Start date: July 10, 2021
Phase: N/A
Study type: Interventional

Investigators hypothesize that the introduction of basic science explanations within the instructional design of case-based training in visual diagnostics will improve students' learning curves, retention, and retrieval of knowledge/skill following a washout period. Research question: In a group of medical students with limited dermatological training, what is the effect of integrating biomedical causal explanations of visual criteria during a prolonged case-based skin cancer training program in visual pattern recognition when compared with an identical instructional design without biomedical explanations? How will the displacement of students' cognitive resources from practicing pattern recognition towards understanding the pattern, affect their learning behavior, learning curve (accuracy and time per diagnosis), and retrieval of pattern recognition skills following a washout period? The above-mentioned research questions will be tested through a randomized trial with an allocation ratio of 1:1. All participants will be trained in skin cancer diagnostics through a mobile application that offers simulation training and learning through written modules about the various differential diagnoses. Approximately half of the participants will be subject to a written content that displays the dermoscopic visual criteria without an explanation while the remaining half will be subject to the dermoscopic criteria + an explanation of the underlying cause. The training program consists of 500 training cases, a 14 day wash-out period, and a final training session of 100 cases.

NCT ID: NCT05068687 Completed - Clinical trials for Head and Neck Neoplasms

Peroperative Assessment of Malignancies of the Head and Neck Using High-resolution 18F-FDG-PET/CT

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

In this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18F-FDG ((18)F-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. Following the resection, the 18F-FDG-infused malignancy will be investigated utilizing a novel high-resolution Positron Emission Tomography (PET) and Computed Tomography (CT) scan. Slicing of the malignancy will be followed by additional PET/CT-scanning and autoradiography of the sliced specimen. The results found during image analysis will be compared to the results of the gold standard of histopathology. As this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.

NCT ID: NCT05068310 Recruiting - Skin Cancer Clinical Trials

Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors

Start date: October 21, 2021
Phase:
Study type: Observational

The incidence of skin cancer has been continuously increasing over the past decades und the number of non melanoma skin cancer is well as melanoma is still going to increase. Invasive biopsy and histological examination represents the gold standard in diagnosis of benign and malignant skin tumors. However, novel technologies such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) have been introduced in dermatology. Multiple studies have shown the applicability of both technologies for diagnosis of skin tumors as well as other skin diseases and to increase the specificity of diagnosis resulting in the reduction of unnecessary biopsies. New technological developments resulted in a high resolution OCT scanner (AMO, Taiwan), which allows vertical and horizontal evaluation (3D) of the skin at cellular resolution and up to a depth of around 400 μm and thus combines the advantages of both above mentioned techniques. ApolloVue® S100 Image System is a FDA-cleared 510(k) Class II medical device. Other non-invasive imaging method (reflectance confocal microscopy and conventional optical coherence tomography) will be used to evaluate a subset of skin lesions.

NCT ID: NCT05047094 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Safety and Efficacy Study for Combinational Treatment of DaRT and Check Point Inhibitor for Recurrent Unresectable or mHNSCC

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

A unique combinational treatment for cancer employing intratumoral diffusing alpha radiation emitter device with check point inhibitor for recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05039801 Recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Start date: September 9, 2021
Phase: Phase 1
Study type: Interventional

To find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied.