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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

October 14, 2010
May 1, 2013
September 2010
April 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01221766 on ClinicalTrials.gov Archive Site
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Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease
The Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease

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.
  • 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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.
  • Graft vs Host Disease
  • Chronic Graft vs Host Disease
  • cGVHD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous HSCT (other then the current HSCT)
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01221766
10-163
Yes
Jennifer Huang, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: Jennifer Huang, MD Children's Hospital Boston
Dana-Farber Cancer Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP