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出境医 / 临床实验 / A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs)
A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs)
Study Description
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.
Study Design
| 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 |
Arms and Interventions
| Group/Cohort |
|---|
|
Patients previously participated in an Aura Biosciences study
Patients with Choroidal Melanoma or Indeterminate Lesions.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Rochelle Summerfelt, MS | (773) 855-8157 | rsummerfelt@aurabiosciences.com | |
| Contact: Abhijit Narvekar, MBBS MS DPM | 617-250-7255 | anarvekar@aurabiosciences.com |
Locations
| United States, Arizona | |
| Retina Associates SW, P.C. | Recruiting |
| Tucson, Arizona, United States, 85710 | |
| Contact: Jenifer Martin 520-733-8584 jmartin@retinatucson.com | |
| Principal Investigator: Cameron Javid, MD | |
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Maria Gutierrez 617-391-5959 MariaElena_Gutierrez@meei.harvard.edu | |
| Contact: Grayson Hanlon 617-573-5627 Grayson_Hanlon@meei.harvard.edu | |
| Principal Investigator: Ivana Kim, MD | |
| United States, Michigan | |
| W. K. Kellogg Eye Center, University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48105 | |
| Contact: Pamela Campbell 734-936-0138 pamtitus@@med.umich.edu | |
| Principal Investigator: Hakan Demirci, MD | |
| Associated Retinal Consultants, PC | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Kendra Mellert 248-288-9132 ext 1315 kmellert@arcpc.net | |
| Principal Investigator: Antonio Capone Jr., MD | |
| United States, Minnesota | |
| Retina Center | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Andi Gilchrist, BS CMSS 612-746-3880 agilchrist@retinadocs.com | |
| Contact: Celeste Moreno 612-746-3880 cmoreno@retinadocs.com | |
| Principal Investigator: Abdhish R Bhavsar, MD | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Zoe Singer 212-305-3236 zs2423@cumc.columbia.edu | |
| Principal Investigator: Brian Marr, MD | |
| United States, Pennsylvania | |
| Wills Eye Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Rachel Schwendeman 215-928-3105 rachel@shields.md | |
| Principal Investigator: Carol Shields, MD | |
| United States, South Carolina | |
| Retina Consultants of Carolina, PA | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Lauren Frazier 864-233-5722 ext 1107 lfrazier@retina-consultants.com | |
| United States, Texas | |
| Retina Consultants of Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Chelsey L Moore, CMSS 713-394-7575 chelsey.moore@houstonretina.com | |
| Principal Investigator: Amy C Schefler, MD | |
Sponsors and Collaborators
Aura Biosciences
Investigators
| Study Director: | Abhijit Narvekar, MBBS MS DPM | Aura Biosciences Inc. |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 3, 2019 | ||||||||
| First Posted Date | May 7, 2019 | ||||||||
| Last Update Posted Date | January 22, 2021 | ||||||||
| Actual Study Start Date | March 27, 2019 | ||||||||
| Estimated Primary Completion Date | December 2029 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs) | ||||||||
| Official Title | A Registry of Patients With Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILs) | ||||||||
| 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. | ||||||||
| 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. |
||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial. | ||||||||
| Condition |
|
||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Patients previously participated in an Aura Biosciences study
Patients with Choroidal Melanoma or Indeterminate Lesions.
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 2029 | ||||||||
| Estimated Primary Completion Date | December 2029 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03941379 | ||||||||
| Other Study ID Numbers | Registry AU-011-401 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
|
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| Responsible Party | Aura Biosciences | ||||||||
| Study Sponsor | Aura Biosciences | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
||||||||
| PRS Account | Aura Biosciences | ||||||||
| Verification Date | January 2021 | ||||||||
