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

NCT01851382 | Completed

• 2 other identifiers: 13012813-C-0128
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ELISA; Spectrometry; Protein Biomarkers; Proteomic Analyses; Natural History

Outcome Measures

Primary Outcomes (1)

• Collect saliva and peripheral blood

  Sample analysis for research.

  End of specimen collection

Study Arms (1)

Cohort 1

Healthy volunteers.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers from the local community.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 23107104 BACKGROUND

• 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.

  PMID: 22806177 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Steven Z Pavletic, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: May 15, 2013
• Primary Completion: July 10, 2014
• Study Completion: February 12, 2015
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

US (1)