RECRUITING

Point of Care Testing for Presence of Current and or Previous T. Gondii Infection

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

This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant. This is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver. This allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.

Official Title

Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection

Quick Facts

Study Start:2020-08-13
Study Completion:2026-08-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04474132

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:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * any adult who is willing to participate in the study
  1. * pregnant women who are in their 17-27 weeks of gestation.

Contacts and Locations

Study Contact

Rima McLeod, M.D.
CONTACT
312-513-6365
rmcleod@uchicago.edu
Marcela Cid
CONTACT
714-376-4412
mcidrosas@uchicago.edu

Principal Investigator

Rima McLeod, M.D.
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Rima McLeod, M.D., PRINCIPAL_INVESTIGATOR, University of Chicago

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 Date2020-08-13
Study Completion Date2026-08-20

Study Record Updates

Study Start Date2020-08-13
Study Completion Date2026-08-20

Terms related to this study

Keywords Provided by Researchers

  • toxoplasma
  • test
  • feasibility

Additional Relevant MeSH Terms

  • Toxoplasma Infections