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Collection of Saliva From Healthy Volunteers for Research


N/A
18 Years
N/A
Open (Enrolling)
Both
Graft vs Host Disease, Graft-Versus-Host Disease

Thank you

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.

Inclusion Criteria


- INCLUSION CRITERIA:

- Healthy individuals (including employees) and other healthy volunteers from all
racial/ethnic groups

- Age 18 years and older, with possible restriction for age-matching to patient
samples.

- Ability of subject to understand and provide written informed consent

- Subjects must participate fully and be willing to comply with the procedures of the
protocol

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

EXCLUSION CRITERIA:

- Active systemic illnesses, immunodeficiency, history of opportunistic infection,
autoimmune disease, immunosuppressive medications

- Prior organ, bone marrow or peripheral blood stem cell transplant

- Acute dental infection

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Collect 5 ml of saliva from healthy volunteers

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Steven Z Pavletic, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

130128

NCT ID:

NCT01851382

Start Date:

April 2013

Completion Date:

April 2018

Related Keywords:

  • Graft Vs Host Disease
  • Graft-Versus-Host Disease
  • ELISA
  • Spectrometry
  • Protein Biomarkers
  • Proteomic Analyses
  • Graft vs Host Disease

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892