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

Completed

• Conditions: Chronic Graft vs Host Disease; cGVHD; Graft vs Host Disease

• Registration Number: NCT01221766
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Primary Completion: 2013-04
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

• Previous HSCT (other then the current HSCT)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adnexal involvement	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.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States