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

Graft vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221766
• Other study ID #: 10-163
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: March 27, 2015
• Start date: September 2010
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Received hematopoietic stem cell transplant

• Meet the diagnostic criteria for cutaneous cGVHD

Exclusion Criteria:

• Previous HSCT (other then the current HSCT)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• cGVHD
• Chronic Graft vs Host Disease
• Graft vs Host Disease

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adnexal involvement	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.	1 year	No