Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Huang, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01221766
First received: October 14, 2010
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Graft vs Host Disease
Chronic Graft vs Host Disease
cGVHD

Study Type: Observational
Study Design: 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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Adnexal involvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2010
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Children's Hospital Boston
  More Information

No publications provided

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
Study First Received: October 14, 2010
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013