Collection of Saliva and/ or Peripheral Blood From Healthy Volunteers for Research
Condition: Graft vs Host Disease; Healthy Volunteer; Graft-Versus-Host Disease
MeSH terms: Graft vs Host Disease
Study type: Observational

Summary: 
      Background:

      - Researchers often collect samples from healthy volunteers to further their research. These
      samples can help better understand serious side effects and complications of transplant
      treatments in patients. This study will collect saliva samples from healthy volunteers.

      Objectives:

      - To collect saliva and blood samples from healthy volunteers for research studies.

      Eligibility:

      - Healthy men ages 30-70 years for Phase I of the study.

      Design:

        -  Participants will be screened with a medical history questionnaire. They will also have
           a brief oral exam to check for any mouth infection.

        -  Participants will provide a saliva sample. The collection process will take about 5
           minutes.

        -  No treatment will be given as part of this study.
    

Detailed description: 
      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 and/or blood sample in order to compare its characteristics with
           those of patients with and without chronic GVHD after allogeneic HSCT. The normal
           control saliva and blood samples will provide a standard of comparison for patient
           saliva and blood samples from ongoing NCI cGVHD related protocols.

      Objective:

      -To collect approximately 5 ml of saliva and/or 18 cc peripheral blood 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 and peripheral blood 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.

        -  Peripheral blood samples may be collected from the consenting subject at the same visit.

        -  Protein assays will be performed on the collected saliva and blood samples.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers from the local community.
      
Keywords: ELISA; Spectrometry; Protein Biomarkers; Proteomic Analyses; Natural History