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Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease

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ClinicalTrials.gov Identifier: NCT01221766
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Jennifer Huang, MD, Dana-Farber Cancer Institute

Brief Summary:
This research study will help us learn more about how chronic graft-versus-host disease affects the skin, hair and nails. We are interested in knowing if hair and nail problems predict worse disease. This information may help us treat patients like you in the future.

Condition or disease
Graft vs Host Disease Chronic Graft vs Host Disease cGVHD

Detailed Description:
  • At the initial visit, participants will have a complete examination of their skin, hair and nails. We will also test muscle strength and movement by moving the participant's arms, legs and neck. Photographs will be taken of the skin, hair and nails of they are abnormal. Blood tests will be done to check the liver and blood cell count. The participant and their legal guardian will answer questions about how the participant feels and about their health.
  • Participants will then be scheduled for follow up visits at 3 months, 6 months, and 12 months. At each subsequent visit the following will be done: A complete examination of the skin, hair and nails; a test of muscle strength; photographs will be repeated; blood tests to check liver and blood cell counts; and questions about how the participant feels and about their health.

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease
Study Start Date : September 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : October 2014





Primary Outcome Measures :
  1. Adnexal involvement [ Time Frame: 1 year ]
    To determine if adnexal involvement predicts worse severity and/or prognosis in chronic GVHD. This will be measured by administration of systemic therapy other than steroids.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The research subject population is children who have received hematopoietic stem cell transplant and developed chronic graft-versus-host disease. All children seen at the pediatric GVHD clinic at the Dana-Farber Cancer Institute will be recruited.
Criteria

Inclusion Criteria:

  • Received hematopoietic stem cell transplant
  • Meet the diagnostic criteria for cutaneous cGVHD

Exclusion Criteria:

  • Previous HSCT (other then the current HSCT)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221766


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jennifer Huang, MD Boston Children’s Hospital

Responsible Party: Jennifer Huang, MD, Instructor in Dermatology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01221766     History of Changes
Other Study ID Numbers: 10-163
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Jennifer Huang, MD, Dana-Farber Cancer Institute:
adnexal
hair and nail
chronic graft vs host disease
children

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases