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A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs)

2019-05-12 17:45:15 | BioPortfolio

Summary

The purpose of this observational research study is to follow participants who have been treated with either AU-011 or observation and/or received standard of care therapy while participating in a previous Aura Biosciences clinical research study to assess the long-term safety and effectiveness of AU-011 and standard of care therapy. This study will collect information from procedures conducted as part of routine follow-up eye care and cancer care.

Description

This is a multi-center long-term observational Registry of patients with Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs) The Registry will initially be open to patients who have previously participated in an Aura Biosciences sponsored clinical trial for their primary Choroidal Melanoma or Indeterminate Lesions.

All patients will be followed for a minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first.

No interventions will be required as part of the Registry. Data collection will be based on information anticipated to be available based on the standard of care for patients with CM or IL; these patients are routinely followed at 6-month intervals by their treating physician.

Study Design

Conditions

Choroidal Melanoma

Location

Associated Retinal Consultants, PC
Royal Oak
Michigan
United States
48073

Status

Recruiting

Source

Aura Biosciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-05-12T17:45:15-0400

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PubMed Articles [1025 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

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