Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2026-04-30

Brief Summary

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Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign compounds (antigens) in the body, which they internalize and process. When DCs uptake foreign antigens, they migrate to secondary lymphoid organs, where the processed antigens are presented to T cells.

Various DC subsets with unique cell lineages, surface protein markers, and tissue localization determinants have been identified. For example, Langerhans cells (LCs) and interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the skin. Though both are expressed in the skin, they differ with respect to their origin and surface protein content and can activate distinct types of immune responses. They may also have different specificities for the capture of antigens and presentation to circulating T cells.

To date, it is unknown what role, if any, the different DC populations that reside or repopulate in the skin play in the development and progression of skin graft-versus-host disease (GVHD) following bone marrow transplant.

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Detailed Description

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Conditions

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Acute Graft-versus-host Disease Acute GVHD Chronic Graft-versus-host Disease Chronic GVHD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1: Acute skin GVHD

* When clinically indicated, patients will undergo a skin biopsy to confirm a suspected diagnosis of acute or chronic GVHD, or to assess the status of their previously diagnosed acute or chronic GVHD. After the necessary samples are obtained for optimal medical care of the patient, two 6 mm punch biopsies (or four 4 mm punch biopsies) will be performed for research purposes, one (or two) of the affected area and one (or two) of a non-affected area (normal skin).
* Patients who have clinical resolution of their acute or chronic GVHD will undergo one additional 6 mm punch biopsy (or two additional 4 mm punch biopsies) of the previously affected area. This additional biopsy should occur within 10 cm of the previous affected area sample.
* With each skin biopsy, peripheral blood will be obtained by venipuncture or cannulation of an indwelling venous access device.
* Two optional skin biopsies. One on day 5-7 of treatment and one on day 28 from the start of treatment.

Skin punch biopsy

Intervention Type PROCEDURE

Peripheral blood draw

Intervention Type PROCEDURE

Arm 2: Chronic skin GVHD

* When clinically indicated, patients will undergo a skin biopsy to confirm a suspected diagnosis of acute or chronic GVHD, or to assess the status of their previously diagnosed acute or chronic GVHD. After the necessary samples are obtained for optimal medical care of the patient, two 6 mm punch biopsies (or four 4 mm punch biopsies) will be performed for research purposes, one (or two) of the affected area and one (or two) of a non-affected area (normal skin).
* Patients who have clinical resolution of their acute or chronic GVHD will undergo one additional 6 mm punch biopsy (or two additional 4 mm punch biopsies) of the previously affected area. This additional biopsy should occur within 10 cm of the previous affected area sample.
* With each skin biopsy, peripheral blood will be obtained by venipuncture or cannulation of an indwelling venous access device.
* Two optional skin biopsies. One on day 5-7 of treatment and one on day 28 from the start of treatment.

Skin punch biopsy

Intervention Type PROCEDURE

Peripheral blood draw

Intervention Type PROCEDURE

Interventions

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Skin punch biopsy

Intervention Type PROCEDURE

Peripheral blood draw

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age at enrollment
* Willing and able to sign the informed consent
* Current diagnosis/suspected diagnosis of acute skin GVHD OR Current diagnosis/suspected diagnosis of chronic skin GVHD