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
|Condition or disease|
|Choroidal Melanoma Indeterminate Lesions of Eye|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
Patients previously participated in an Aura Biosciences study
Patients with Choroidal Melanoma or Indeterminate Lesions.
- 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.
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
|Contact: Rochelle Summerfelt, MS||(773) email@example.com|
|Contact: Abhijit Narvekar, MBBS MS DPMfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Rachel Schwendeman 215-928-3105 firstname.lastname@example.org|
|Principal Investigator: Carol Shields, MD|
|Study Director:||Abhijit Narvekar, MBBS MS DPM||Aura Biosciences Inc.|