NCT01221766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

October 14, 2010

Last Update Submit

March 27, 2015

Conditions

Keywords

adnexalhair and nailchronic graft vs host diseasechildren

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Previous HSCT (other then the current HSCT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Jennifer Huang, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Dermatology

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 15, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2013

Study Completion

October 1, 2014

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations