Graft vs Host DiseaseNCT01851382
Collection of Saliva and/ or Peripheral Blood From Healthy Volunteers for Research
An observational study of Graft vs Host Disease and Healthy Volunteer, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Graft vs Host Disease, Healthy Volunteer, Graft-Versus-Host Disease
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2013to 12 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers from the local community.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Keywords
- ELISA, Spectrometry, Protein Biomarkers, Proteomic Analyses, Natural History
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect saliva and peripheral blood
Sample analysis for research.
Measured: End of specimen collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study start15 May 2013
- Primary completion10 Jul 2014
- Study completion12 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven Z Pavletic, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851382
- Sponsor's protocol ID
- 130128
- Other IDs
- 13-C-0128
- Status last verified
- Jul 2022
- First submitted
- 8 May 2013
- Last updated
- 11 Jul 2022
- Results posted
- No
Publications
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.
PubMed 23107104Bassim 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.
PubMed 22806177
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Saliva and/ or Peripheral Blood From Healthy Volunteers for Research
- ClinicalTrials.gov ID
- NCT01851382
- Acronym / sponsor ID
- 130128
- Keywords
- ELISA, Spectrometry, Protein Biomarkers, Proteomic Analyses, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 15 May 2013 (actual)
- Primary completion
- 10 Jul 2014 (actual)
- Study completion
- 12 Feb 2015 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Healthy volunteers. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers from the local community.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect saliva and peripheral blood
Time frame: End of specimen collection
Sample analysis for research.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 23107104Mays 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.
- Background: PubMed 22806177Bassim 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Z Pavletic, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft vs Host Disease and Healthy Volunteer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect saliva and peripheral blood (time frame: End of specimen collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01851382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.