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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03941379
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Aura Biosciences

Brief 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.

Condition or disease
Choroidal Melanoma Indeterminate Lesions of Eye

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs)
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Group/Cohort
Patients previously participated in an Aura Biosciences study
Patients with Choroidal Melanoma or Indeterminate Lesions.



Primary Outcome Measures :
  1. Incidence of Treatment Related Adverse Events [ Time Frame: 5 years ]
    Treatment related adverse events will be assessed and graded using CTCAE v5.0. The number and percentage of patients with treatment related adverse events will be summarized.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial.
Criteria

Inclusion Criteria:

  • Have been clinically diagnosed with primary CM or IL at the time of entry to a previous Aura Biosciences sponsored clinical trial.
  • Have received AU-011 or assigned to an observation cohort in a previous Aura sponsored clinical trial.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941379


Contacts
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Contact: Rochelle Summerfelt, MS (773) 855-8157 rsummerfelt@aurabiosciences.com
Contact: Abhijit Narvekar, MBBS MS DPM 617-250-7255 anarvekar@aurabiosciences.com

Locations
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United States, Michigan
Associated Retinal Consultants, PC Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Kendra Mellert    248-288-9132 ext 1315      
Principal Investigator: Antonio Capone Jr., MD         
United States, Pennsylvania
Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Carol Shields, MD    215-928-7161    carol@shields.md   
Contact: Rachel Schwendeman    215-928-3105    rachel@shields.md   
Principal Investigator: Carol Shields, MD         
Sponsors and Collaborators
Aura Biosciences
Investigators
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Study Director: Abhijit Narvekar, MBBS MS DPM Aura Biosciences Inc.

Additional Information:
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Responsible Party: Aura Biosciences
ClinicalTrials.gov Identifier: NCT03941379     History of Changes
Other Study ID Numbers: Registry AU-011-401
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aura Biosciences:
Choroidal Melanoma
Indeterminate Lesions of Eye

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas