Trials Sponsors Conditions Drugs Pricing

Conditions

Iris Tumor

Keywords

IrisTumorMelanomaOptical Coherence Tomography (OCT)Angiography

Outcome Measures

Primary Outcomes (1)

Tumor Thickness in Benign vs Malignant Iris Lesions
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.
6 months

Secondary Outcomes (3)

Tumor Area in Benign vs Malignant Iris Lesions
6 months
Tumor Volume in Benign vs Malignant Iris Lesions
6 months
Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures
6 months after treatment

Study Arms (2)

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.

Healthy Controls

This group will consist of 50 adults age 18 and older who have healthy eyes.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adults age 18 or older with either healthy eyes or iris tumors

You may qualify if:

Eyes with diagnosis of melanotic or amelanotic iris tumors

Sponsors & Collaborators

Oregon Health and Science University
Otherlead
National Eye Institute (NEI)
NIHcollaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Denzil Romfh, ODCONTACT503-494-4351 romfhd@ohsu.edu

Humberto Martinez, COTCONTACT503-494-7712 martinhu@ohsu.edu

MeSH Terms

Conditions

Iris NeoplasmsNeoplasmsMelanoma

Condition Hierarchy (Ancestors)

Uveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesIris DiseasesUveal DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and Melanomas

Study Officials

David Huang, MD, PhD
Oregon Health and Science University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Denzil Romfh, OD

CONTACT

503-494-4351 romfhd@ohsu.edu

Humberto Martinez, COT

CONTACT

503-494-7712

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Peterson Professor of Ophthalmology & Professor of Biomedical Engineering

Study Record Dates

First Submitted

November 29, 2018

First Posted

January 18, 2019

Study Start

June 20, 2018

Actual (reported)

Primary Completion

December 2026

Estimated

Observational Study of Iris Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Iris Tumors

Healthy Controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Iris Tumors

Healthy Controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations