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出境医 / 临床实验 / Observational Study of Iris Tumors
Observational Study of Iris Tumors
Study Description
Brief Summary:
This is an observational study using OCT angiography to assist with tumor characterization in melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be compared to eyes with various types of iris tumors.
| Condition or disease |
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| Iris Tumor |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Observational Study of Iris Tumors |
| Actual Study Start Date : | June 20, 2018 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
Arms and Interventions
| Group/Cohort |
|---|
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Iris Tumors
This group will consist of 50 adults age 18 or older who have been diagnosed with either melanotic or amelanotic iris tumors. Iris tumor diagnosis will be confirmed by biopsy when possible or based upon clinical features (if patient declines biopsy or if not medically indicated) according to standard-of-care guidelines.
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Healthy Controls
This group will consist of 50 adults age 18 and older who have healthy eyes.
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Outcome Measures
Primary Outcome Measures :
- Tumor Thickness in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]OCT/OCTA will be used to compare tumor thickness measurements against the conventional Ultrasonic Biomicroscopy (UBM) device. Tumor thickness will be measured in millimeters, and growth of 0.5 mm or greater will be used to differentiate malignant from benign lesions.
Secondary Outcome Measures :
- Tumor Area in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.
- Tumor Volume in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ]Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.
- Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures [ Time Frame: 6 months after treatment ]Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Adults age 18 or older with either healthy eyes or iris tumors
Criteria
Inclusion Criteria for tumor group:
- Eyes with diagnosis of melanotic or amelanotic iris tumors
Inclusion Criteria for healthy control group:
- Eyes without iris defects or lesions
Exclusion Criteria (both groups):
- Inability to give informed consent
- Inability to maintain stable fixation for OCT imaging
- Inability to commit to required study visits
- Eyes with concurrent retinal diseases, glaucoma, or conditions that in the opinion of the investigators might affect iris circulation
- Mature cataracts if found to limit visual potential to worse than 20/40
Contacts and Locations
Contacts
| Contact: Denzil Romfh, OD | 503-494-4351 | romfhd@ohsu.edu | |
| Contact: Humberto Martinez, COT | 503-494-7712 | martinhu@ohsu.edu |
Locations
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu | |
| Contact: Humberto Martinez, COT 503-494-7712 martinhu@ohsu.edu | |
Sponsors and Collaborators
Oregon Health and Science University
National Eye Institute (NEI)
Investigators
| Principal Investigator: | David Huang, MD, PhD | Oregon Health and Science University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | November 29, 2018 | ||||||||
| First Posted Date | January 18, 2019 | ||||||||
| Last Update Posted Date | March 26, 2021 | ||||||||
| Actual Study Start Date | June 20, 2018 | ||||||||
| Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Tumor Thickness in Benign vs Malignant Iris Lesions [ Time Frame: 6 months ] OCT/OCTA will be used to compare tumor thickness measurements against the conventional Ultrasonic Biomicroscopy (UBM) device. Tumor thickness will be measured in millimeters, and growth of 0.5 mm or greater will be used to differentiate malignant from benign lesions.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Observational Study of Iris Tumors | ||||||||
| Official Title | Observational Study of Iris Tumors | ||||||||
| Brief Summary | This is an observational study using OCT angiography to assist with tumor characterization in melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be compared to eyes with various types of iris tumors. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Adults age 18 or older with either healthy eyes or iris tumors | ||||||||
| Condition | Iris Tumor | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 2023 | ||||||||
| Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria for tumor group:
Inclusion Criteria for healthy control group:
Exclusion Criteria (both groups):
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03809585 | ||||||||
| Other Study ID Numbers | 6612-IRIS R01EY028755 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | David Huang, Oregon Health and Science University | ||||||||
| Study Sponsor | Oregon Health and Science University | ||||||||
| Collaborators | National Eye Institute (NEI) | ||||||||
| Investigators |
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| PRS Account | Oregon Health and Science University | ||||||||
| Verification Date | March 2021 | ||||||||