Chronic Graft-versus-host DiseaseNCT02411474
Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD
An observational study of Chronic Graft-versus-host Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Graft-versus-host Disease
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Aug 2014
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Male or non-pregnant female patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.
Who may be able to join
- The patients patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.
Who cannot join
- The patients with histories of ocular surgery; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease, as well as patients with long-term use of topical ocular medications except artificial tears.
Trial locations and contacts
1 site in 1 country.
About this study
Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity.
- Conditions
- Chronic Graft-versus-host Disease
- Keywords
- stem cell transplantation (SCT)
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
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 |
|---|---|---|
| With or without newly diagnosed chronic GVHD after SCT | The patients developed chronic GVHD after SCT/ The patients did not developed chronic GVHD after SCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear cytokine
comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay
Measured: 3-12 month after SCT
ocular surface status
Measured: 3-12 month after SCT
tear film break-up time
Measured: 3-12 month after SCT
conjunctival injection
Measured: 3-12 month after SCT
Schirmer's test I
Measured: 3-12 month after SCT
ocular surface disease index
Measured: 3-12 month after SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411474
- Sponsor's protocol ID
- 4-2014-0008
- Status last verified
- Apr 2015
- First submitted
- 5 Mar 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fraser CJ, Bhatia S, Ness K, Carter A, Francisco L, Arora M, Parker P, Forman S, Weisdorf D, Gurney JG, Baker KS. Impact of chronic graft-versus-host disease on the health status of hematopoietic cell transplantation survivors: a report from the Bone Marrow Transplant Survivor Study. Blood. 2006 Oct 15;108(8):2867-73. doi: 10.1182/blood-2006-02-003954. Epub 2006 Jun 20.
PubMed 16788100
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD
- ClinicalTrials.gov ID
- NCT02411474
- Acronym / sponsor ID
- 4-2014-0008
- Conditions
- Chronic Graft-versus-host Disease
- Keywords
- stem cell transplantation (SCT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Apr 2015 (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.
Investigate the profiles of tear cytokines in patients who underwent stem cell transplantation (SCT) and attempted to determine the applicability of tear cytokines in the diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers of chronic ocular GVHD severity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With or without newly diagnosed chronic GVHD after SCT | – | –The patients developed chronic GVHD after SCT/ The patients did not developed chronic GVHD after SCT |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male or non-pregnant female patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.
Key inclusion criteria (1 listed)
- The patients patients aged 20-60 years who visited the clinic 3-12 months after SCT were included in the study.
Key exclusion criteria (1 listed)
- The patients with histories of ocular surgery; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease, as well as patients with long-term use of topical ocular medications except artificial tears.
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
tear cytokine
Time frame: 3-12 month after SCT
comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay
ocular surface status
Time frame: 3-12 month after SCT
tear film break-up time
Time frame: 3-12 month after SCT
conjunctival injection
Time frame: 3-12 month after SCT
Schirmer's test I
Time frame: 3-12 month after SCT
ocular surface disease index
Time frame: 3-12 month after SCT
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 8 Apr 2015.
- Background: PubMed 16788100Fraser CJ, Bhatia S, Ness K, Carter A, Francisco L, Arora M, Parker P, Forman S, Weisdorf D, Gurney JG, Baker KS. Impact of chronic graft-versus-host disease on the health status of hematopoietic cell transplantation survivors: a report from the Bone Marrow Transplant Survivor Study. Blood. 2006 Oct 15;108(8):2867-73. doi: 10.1182/blood-2006-02-003954. Epub 2006 Jun 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Graft-versus-host Disease, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 1 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 8 Apr 2015. 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 South Korea. 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?
tear cytokine (time frame: 3-12 month after SCT). The study lists 6 primary outcomes in all. 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 NCT02411474, which also lists 1 linked publication.
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 8 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.