The Natural History of Graft-Versus-Host Disease in the Eyes

NCT01369914 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2019-12-03

No results posted yet for this study

Summary

Background:

* Stem cell transplantation (SCT) is used to treat some kinds of cancer, blood cell disorders, and immune disorders. Stem cells from a donor s blood are used to replace the recipient s stem cells in the bone marrow. The recipient s bone marrow can then produce new blood cells. Some of these new cells involved in the immune system are like the donor s cells. Sometimes immune cells from the SCT attack the recipient s normal tissues, including the eyes. This type of immune attack is called graft-versus-host disease, or GVHD.
* The symptoms of ocular GVHD include eye pain, irritation, dryness, and inflammation. When it is severe and if it does not respond well to treatment, ocular GVHD may also cause vision loss.

Objective:

\- To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had stem cell transplantation.

Eligibility:

* Participants must be at least 18 years of age.
* They must be taking part in a study at the National Cancer Institute (NCI) or the National Heart, Lung and Blood Institute (NHLBI).
* They must have a SCT scheduled within the next 30 days.

Design:

* The study lasts for 1 year and includes six visits to the National Eye Institute. (There is an optional visit about 1 month before your SCT.) When possible, visits for this study will be scheduled so that they can be done on the same day as your visits for the NCI or NHLBI protocol that you are taking part in.
* At each visit, participants will have a medical exam and an eye history will be taken. They will have an eye exam and a test to measure the ability to make tears. Those in the study will also have tear fluid collected for analysis in a lab. Tear fluid collection is a painless process. Blood will be drawn during certain visits if it has not already been collected by the transplant team.

Conditions

  • Graft-Versus-Host Disease

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Rachel J Bishop, M.D. · National Eye Institute (NEI)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-20
Completion
2016-02-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369914 on ClinicalTrials.gov