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OpenTrials
Completed

NCT Number: NCT01221766

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.

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Key information

Conditions

Graft vs Host Disease Chronic Graft vs Host Disease Immune System Diseases cGVHD

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous HSCT (other then the current HSCT)

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Oct 15, 2010
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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