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NCT03602599 · ClinicalTrials.gov registry record

Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls

A clinical trial of Graft-Versus-Host Disease, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

Recruiting
Registry status
500
Enrollment target
1
Study location

NCT03602599 is a study of Graft-Versus-Host Disease that is actively recruiting participants, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 500 participants, above the 70-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (614% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT03602599, a study of Graft-Versus-Host Disease, is actively recruiting participants, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).

RECRUITING
Registry status
500 participants
Enrollment target
1
Study location

Study Summary

Background: This study follows people who have had, or will soon have, a transplant using stem cells from another person. This is known as an allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (cGVHD) can happen after HSCT. cGVHD can cause mouth problems and more serious issues. Researchers want to study changes in the mouth that might indicate cGVHD. Objective: To identify cGVHD in the mouth and better understand the development, treatment, and progress of post-transplant changes in the mouth. Eligibility: Adults at least 18 years old who will soon undergo HSCT or have had one in the past 3 years Healthy adults at least 18 years old Design: All participants will have a screening visit and baseline visit. They will last 60-90 minutes. Over these two visits, participants will have: Medical and dental history Dental exam. Questions about their eating habits and general health Blood drawn through a needle in the arm Vital signs taken Pictures of their mouth and lips taken Questions about their oral health, including about pain, sensitivity, or dryness Saliva samples taken. Participants will spit into a sterile plastic tube. Swabs taken of the mouth and some of the saliva, plaque, and fluid from the spaces between teeth and gums. Participants may also have: A piece of skin taken (biopsy) from the inner lining of the cheeks A piece of skin taken (biopsy) from the lower lip Dental X-rays Urine pregnancy test Most participants will have at least 7 study visits over 3 years. They will meet with a dentist and repeat baseline tests.

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2018-11-15
Est. Completion 2037-03-03

What the Registry Record Tells You About NCT03602599

The ClinicalTrials.gov registry entry for NCT03602599 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 70-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (614% higher). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 0 interventions.

NCT03602599 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT03602599 about?

NCT03602599 is a clinical study titled "Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls". Background: This study follows people who have had, or will soon have, a transplant using stem cells from another person. This is known as an allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (cGVHD) can happen after HSCT. cGVHD can cause mouth problems and more seriou...

What is the current status of trial NCT03602599?

This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2018-11-15. Estimated completion is 2037-03-03.

What conditions does trial NCT03602599 study?

This clinical trial studies the following conditions: Graft-Versus-Host Disease.

Who is sponsoring clinical trial NCT03602599?

This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03602599 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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