Uveal melanoma (UM) is a prevalent intraocular cancer, with approximately 3, 000 new cases annually and an estimated total of 60, 000-70, 000 affected individuals in the US. This malignancy poses a distressing reality as around 50% of patients develop metastatic diseases within 5 years, leading to devastating consequences for patients and healthcare providers. Current methods for predicting metastasis risk rely on invasive needle biopsies based on gene expression profiles (GEP), which are performed once and can cause discomfort and complications. The urgent need to address this challenge calls for the development of an effective and least invasive prognostic tool that can accurately predict metastatic risk, enhance safety, and guide treatment decisions worldwide, thereby offering better surveillance for patients with reduced costs and alleviating their concerns. To tackle this challenge, we've established a novel approach for predicting metastasis risk using proteomic analysis of aqueous humor (AH), the clear fluid of the front chamber from eyes. AH paracentesis, a safe procedure routinely performed in ophthalmology practice for decades, enabled the identification of differentially expressed proteins in AH samples. With this STTR Phase 1 application, we aim to develop a fit-for-purpose test based on our innovation, aiming to provide an easy-to-use pre-clinical test that utilizes safely accessible AH-based protein biomarkers, ultimately improving prediction accuracy and informing patient care.
Public Health Relevance Statement: Narrative Our project aims to create a safer method for predicting uveal melanoma metastatic risk. Instead of invasive biopsies, we use routine aqueous humor paracentesis, ensuring safety and accuracy. Analyzing ocular fluid proteins, we aim to develop a precise test for accurate metastasis risk assessment, enhancing treatment decisions and patient care. Terms: <21+ years old; Active Follow-up; Address; Adult; Adult Human; Affect; Aqueous Humor; Assay; Bioassay; Biological Assay; Biological Markers; Biopsy; Body Tissues; CLIA accredited; CLIA approved; CLIA certified; CLIA compliant; CLIA licensed; Cancers; Children's Hospital; Classification; Clinical; Collaborations; Data; Development; Diagnostic; Disease; Disorder; Distress; Elements; Ensure; Evaluation; Expression Signature; Eye diseases; Future; Gene Expression Profile; Goals; Health Care Providers; Health Personnel; Healthcare Providers; Healthcare worker; Hour; Human; Individual; Intraocular Fluid; Intraocular Melanoma; Legal patent; Licensing; Liquid substance; Logistic Regressions; Los Angeles; Malignant Neoplasms; Malignant Tumor; Marketing; Medical center; Melanoma Metastasis; Melanoma patient; Metastasis; Metastasize; Metastatic Lesion; Metastatic Mass; Metastatic Melanoma; Metastatic Neoplasm; Metastatic Tumor; Methods; Modeling; Modern Man; Needle biopsy procedure; Neoplasm Metastasis; Ophthalmology; Outcome; Paracentesis; Patents; Patient Care; Patient Care Delivery; Patients; Pediatric Hospitals; Performance; Phase; Preclinical Testing; Predicting Risk; Price; Proteins; Proteomics; Protocol; Protocols documentation; ROC Analyses; ROC Curve; Reaction; Retrospective cohort; Rights; Risk; Risk Assessment; STTR; Safety; Sampling; Secondary Neoplasm; Secondary Tumor; Secure; Sensitivity and Specificity; Site; Small Business Technology Transfer Research; Specificity; Systematics; Technology; Temperature; Testing; Time; Tissues; Titrations; Uveal Melanoma; Validation; Variant; Variation; active followup; adulthood; bio-markers; biobank; biologic marker; biomarker; biorepository; cancer metastasis; care for patients; care of patients; caring for patients; clinical practice; cohort; comparative; cost; developmental; differential expression; differentially expressed; experiment; experimental research; experimental study; experiments; eye chamber; eye disorder; fluid; follow up; follow-up; followed up; followup; forecasting risk; gene expression pattern; gene expression signature; health care personnel; health care worker; health provider; health workforce; healthcare personnel; improved; indexing; innovate; innovation; innovative; liquid; malignancy; medical personnel; multiplex assay; needle biopsy; neoplasm/cancer; new approaches; new diagnostics; next generation diagnostics; novel; novel approaches; novel diagnostics; novel strategies; novel strategy; ocular disease; ocular disorder; operation; operations; ophthalmopathy; pre-clinical testing; predict risk; predict risks; predicted risk; predicted risks; predicting risks; predictive risk; predicts risk; pricing; procedure safety; prognostic tool; protein biomarkers; protein expression; protein markers; protocol development; receiver operating characteristic analyses; receiver operating characteristic curve; risk prediction; risk predictions; safe procedure; sample collection; specimen collection; time interval; tool; transcriptional differences; transcriptional profile; transcriptional signature; treatment provider; tumor cell metastasis; uvea melanoma; validations
