Risultati per: Linee guida sul melanoma cutaneo

Coinvolto cardiochirurgo del Sant’Orsola, ‘sfida è prevenzione’

This case series identifies patient-level and tumor-level characteristics of melanoma in 48 Black patients at 2 tertiary care centers.

This diagnostic study investigates the performance of a privacy-preserving federated learning approach vs a classical centralized and ensemble learning approach for artificial intelligence–based melanoma diagnostics.

Curata da Arrigoni, Malafarina e Sani e promossa dalla Cpo

Basata sui linfociti estratti dal tumore, moltiplicati e reinfusi

Ridurranno del 70% gli esami inutili

Introduction
Inflammation is a hallmark of cancer and is involved in tumour growth and dissemination. However, the hallmarks of cancer are also the hallmarks of wound healing, and modulating the wound inflammatory response and immune contexture in relation to cancer surgery may represent effective targets of therapies.
Repurposing anti-inflammatory drugs in a cancer setting has gained increasing interest in recent years. Interestingly, the known and thoroughly tested antifibrinolytic drug tranexamic acid reduces the risk of bleeding, but it is also suggested to play important roles in anti-inflammatory pathways, improving wound healing and affecting anti-carcinogenic mechanisms.
As a novel approach, we will conduct a randomised controlled trial using perioperative treatment with tranexamic acid, aiming to prevent early relapses by >10% for patients with melanoma.

Methods and analysis
Design: investigator-initiated parallel, two-arm, randomised, blinded, Danish multicentre superiority trial.
Patients: ≥T2 b melanoma and eligible for sentinel lymph node biopsy (n=1204).
Project drug: tranexamic acid or placebo.
Treatment: before surgery (intravenous 15 mg/kg) and daily (peroral 1000 mg x 3) through postoperative day 4.
Primary outcome: relapse within 2 years after surgery.
Primary analysis: risk difference between the treatment arms (2 test).
Secondary outcomes: postoperative complications, adverse events and survival.
Inclusion period: summer 2023 to summer 2026.

Ethics and dissemination
The trial will be initiated during the summer of 2023 and is approved by the National Committee on Health Research Ethics, the Danish Medicine Agency, and registered under the Data Protection Act. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Patients included in the study will adhere to normal Danish treatment protocols and standards of care, and we expect only mild and temporary side effects. Positive and negative results will be published in peer-reviewed journals, with authorships adhering to the Vancouver rules.

Trial registration number
NCT05899465; ClinicalTrials.gov Identifier.

Introduction
Diagnosing invasive cutaneous melanoma (CM) can be challenging due to subjectivity in distinguishing equivocal nevi, melanoma in situ and thin CMs. The underlying molecular mechanisms of progression from nevus to melanoma must be better understood. Identifying biomarkers for treatment response, diagnostics and prognostics is crucial. Using biomedical data from biobanks and population-based healthcare data, translational research can improve patient care by implementing evidence-based findings. The BioMEL biobank is a prospective, multicentre, large-scale biomedical database on equivocal nevi and all stages of primary melanoma to metastases. Its purpose is to serve as a translational resource, enabling researchers to uncover objective molecular, genotypic, phenotypic and structural differences in nevi and all stages of melanoma. The main objective is to leverage BioMEL to significantly improve diagnostics, prognostics and therapy outcomes of patients with melanoma.

Methods and analysis
The BioMEL biobank contains biological samples, epidemiological information and medical data from adult patients who receive routine care for melanoma. BioMEL is focused on primary and metastatic melanoma, but equivocal pigmented lesions such as clinically atypical nevi and melanoma in situ are also included. BioMEL data are gathered by questionnaires, blood sampling, tumour imaging, tissue sampling, medical records and histopathological reports.

Ethics and dissemination
The BioMEL biobank project is approved by the national Swedish Ethical Review Authority (Dnr. 2013/101, 2013/339, 2020/00469, 2021/01432 and 2022/02421-02). The datasets generated are not publicly available due to regulations related to the ethical review authority.

Trial registration number
NCT05446155.