RECRUITING

Clinical and Genetic Analysis of ROP

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of childhood blindness in the United States and throughout the world. The investigators feel that this study will result in specific knowledge discovery about ROP, as well as general knowledge about how image-based data and genetic data can be combined to better understand clinical disease. Participants will be recruited from the neonatal intensive care unit (NICU) at OHSU, along with 4 collaborating institutions (William Beaumont Hospital, Stanford University, University of Illinois Chicago and University of Utah). Hospitalized infants who receive ROP screening examinations for routine care will be eligible for this study, and will be offered the opportunity to participate. Subjects who provide informed consent will have clinical data from routine care collected along with demographic characteristics, results from routine ROP screening examinations, presence of systemic disease or risk factors. Retinal photographs will be taken during these routine eye exams, using a commercially-available camera that has been FDA-cleared for taking pictures from retinas of premature infants. These retinal pictures do not contain any identifiable patient information, and are taken as routine standard of care. The long-term goal of this research is to establish a quantitative framework for retinopathy of prematurity (ROP) care based on clinical, imaging, genetic, and informatics principles. The investigators have previously recruited and rigorously phenotyped and genotyped a large study cohort, including implementation of a novel reference standard diagnosis; and built a world-class research consortium for image, genetic, and bioinformatics analysis.

Official Title

Clinical and Genetic Analysis of Retinopathy of Prematurity

Quick Facts

Study Start:2011-07-01
Study Completion:2030-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04420156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * All infants hospitalized at participating Neonatal Intensive Care Units will be eligible for the study if they meet plublished criteria for requiring ROP screening examination, or if they are transferred to the study center for specialized ophthalmic care. These eligibility criteria are identical at each study center, and match what is done in standard clinical practice according to national guidelines published jointly by the American Academy of Pediatrics, American Academy of Ophthalmology, and American Associatioin for Pediatric Ophthalmology and Strabismus (AAP-AAO, Pediatrics, 2013).
  1. * Patients will be excluded if they have structural ocular anomalies, or if they are considered unstable for examintion by their attending neonatologist.

Contacts and Locations

Study Contact

John P Campbell, M.D.
CONTACT
503-494-7891
campbelp@ohsu.edu
Susan R Ostmo, M.S.
CONTACT
503-494-7450
ostmo@ohsu.edu

Principal Investigator

John P Campbell, M.D.
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Stanford University
Palo Alto, California, 94303
United States
University of Illinois Chicago
Chicago, Illinois, 60607
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
University of Utah
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • John P Campbell, M.D., PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-07-01
Study Completion Date2030-05-31

Study Record Updates

Study Start Date2011-07-01
Study Completion Date2030-05-31

Terms related to this study

Keywords Provided by Researchers

  • ophthalmology
  • neonatology
  • prematurity

Additional Relevant MeSH Terms

  • Retinopathy of Prematurity