Trial Information

Collection of Saliva From Healthy Volunteers for Research

Background:

- Chronic graft-versus-host disease (cGVHD) is a severe immunological complication that
occurs after allogeneic hematopoietic stem cell transplantation (HSCT). Although oral
cGVHD occurs in > 25% of cGVHD patients and leads to decreased quality of life, its
etiology is poorly understood.

- The primary objective of the present protocol is to enroll normal volunteers who will
contribute a saliva sample in order to compare its characteristics with those of
patients with and without chronic GVHD after allogeneic HSCT. The normal control saliva
samples will provide a standard of comparison for patient saliva samples from ongoing
NCI cGVHDrelated protocols.

Objective:

-To collect approximately 5 ml of saliva from healthy volunteers as needed to support

research activities.

Eligibility:

- Healthy individuals (including employees) all racial/ethnic groups, aged 18 years or
older.

- Volunteers must be willing to undergo saliva collection.

- No active illnesses, immunodeficiency, history of opportunistic infection, autoimmune
disease, immunosuppressive medications or prior organ, bone marrow or peripheral blood
stem cell transplant.

- Ability of subject to understand and provide written informed consent.

- Phase I of the study will be restricted to males, age 30-70 years

Design:

- Healthy volunteers will be offered the opportunity to participate in this protocol.

- A basic clinical dental assessment will be done.

- Saliva samples will be collected from the consenting subject.

- Protein assays will be performed on the collected saliva sample.