Collection of Saliva and/ or Peripheral Blood From Healthy Volunteers for Research

Healthy Volunteer Clinical Trial

Official title:

Collection of Saliva and/ or Peripheral Blood From Healthy Volunteers for Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851382
• Other study ID #: 130128
• Secondary ID: 13-C-0128
• Status: Completed
• Start date: May 15, 2013
• Est. completion date: February 12, 2015

Study information

• Verified date: July 2022
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 12, 2015
• Est. primary completion date: July 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease
• Healthy Volunteer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bassim CW, Ambatipudi KS, Mays JW, Edwards DA, Swatkoski S, Fassil H, Baird K, Gucek M, Melvin JE, Pavletic SZ. Quantitative salivary proteomic differences in oral chronic graft-versus-host disease. J Clin Immunol. 2012 Dec;32(6):1390-9. doi: 10.1007/s10875-012-9738-4. Epub 2012 Jul 18. — View Citation

Mays JW, Fassil H, Edwards DA, Pavletic SZ, Bassim CW. Oral chronic graft-versus-host disease: current pathogenesis, therapy, and research. Oral Dis. 2013 May;19(4):327-46. doi: 10.1111/odi.12028. Epub 2012 Oct 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect saliva and peripheral blood	Sample analysis for research.	End of specimen collection

External Links

•   NIH Clinical Center Detailed Web Page