Allo-SCTNCT00935324
The Role of CK18F in Predicting Graft-Versus-Host Disease (GvHD)
An observational study of Allo-SCT, run by Heidelberg University at 1 site in Germany.
Trial summary
Prospective, within-subject controlled study on multiple subject groups to evaluate the meaning of CK18-fragments in the diagnosis, biological activity and prognosis of graft-versus-host disease (GvHD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allo-SCT
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to May 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for allo-SCT
Who may be able to join
- Group A:
- admission for allogenic SCT
- age >= 18 years
- ability of subject to understand character and individual consequences of this clinical trial
- written informed consent
- Group B:
Show all 10Show fewer
- healthy male of female
- age >= 18 years
- ability of subject to understand character and individual consequences of this clinical trial
- written informed consent
Who cannot join
- Group A:
- no specific exclusion criteria
- Group B:
- prolonged bleeding, hemorrhagic diathesis or other indications for clotting disorders in the medical history
- prolonged or intense menses in females
- any other current medical condition or previous disease which in the opinion of investigator may influence subject safety or interfere with the study objective
- intake of any study drug
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg, 69120
Thomas Luft, MD, +49(0)622142 ext. 3349, Thomas.Luft@med.uni-heidelberg.de
About this study
Official title: CK18-Fragments as Tools for Evaluating Diagnosis, Biological Activity, and Prognosis of Graft-Versus-Host Disease
Prospective, within-subject controlled study on multiple subject groups to evaluate the meaning of CK18-fragments in the diagnosis, biological activity and prognosis of graft-versus-host disease (GvHD). Groups consist of patients scheduled for allogenic stem cell transplantation (allo-SCT) (Group A) and healthy voluntary blood donors (Group B).
Read the detailed description
Given the difficulties in assessing diagnosis, severity and biological activity of GvHD by clinical means only, objective parameters for specific GvHD assessment are highly desirable. Criteria for appropriate GvHD biomarkers have recently been defined, thereby stating that suitable validated markers for monitoring of chronic GvHD are still lacking. CK18-F is the first marker that mirrors the pathogenetic endpoint of GvHD i.e. GvHD-induced apoptotic activity in critical epithelial organs (bowel and liver). It represents a new class of GvHD markers which are complementary to the previously recognized immune activation parameters and might thereby be valuable for establishing serological signatures diagnostic for GvHD. This marker may allow distinguishing active GvHD from irreversible end organ damage and other clinical conditions commonly observed after transplant.
The aim of this study is to evaluate if diagnostic and therapeutic decisions in the clinical management of hepato-intestinal GvHD may be based on the measurement of CK18-F levels.
- Conditions
- Allo-SCT
- Keywords
- allo-SCT, GvHD, CK18-F
- 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 |
|---|---|---|
| Group A: patients following allo-SCT | Patients scheduled for allo-SCT fulfilling all inclusion criteria | |
| Group B - healthy controls | healthy voluntary blood donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F
Measured: Group A: after allo-SCT for 1 years or until GvHD occures
Secondary outcomes (3)
Response to therapy
Measured: 3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD
other serum markers such as sCD25, sCD40L, sFASL, sFAS, cytochrome C, sCD141 correlate with the achievement of complete responses
Measured: after allo-SCT for 1 year or until GvHD occurres
CK18-F levels in the absence of a clinically diagnosed GvHD
Measured: after allo-SCT for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allo-SCTStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regensburg
- Investigators
- Thomas Luft, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935324
- Sponsor's protocol ID
- HD/R-01
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CK18-Fragments as Tools for Evaluating Diagnosis, Biological Activity, and Prognosis of Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT00935324
- Acronym / sponsor ID
- HD/R-01
- Conditions
- Allo-SCT
- Keywords
- allo-SCT, GvHD, CK18-F
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University of Regensburg
- Study start
- Feb 2009
- Primary completion
- Mar 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 9 Jul 2009 (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.
Prospective, within-subject controlled study on multiple subject groups to evaluate the meaning of CK18-fragments in the diagnosis, biological activity and prognosis of graft-versus-host disease (GvHD). Groups consist of patients scheduled for allogenic stem cell transplantation (allo-SCT) (Group A) and healthy voluntary blood donors (Group B).
Detailed description
Given the difficulties in assessing diagnosis, severity and biological activity of GvHD by clinical means only, objective parameters for specific GvHD assessment are highly desirable. Criteria for appropriate GvHD biomarkers have recently been defined, thereby stating that suitable validated markers for monitoring of chronic GvHD are still lacking. CK18-F is the first marker that mirrors the pathogenetic endpoint of GvHD i.e. GvHD-induced apoptotic activity in critical epithelial organs (bowel and liver). It represents a new class of GvHD markers which are complementary to the previously recognized immune activation parameters and might thereby be valuable for establishing serological signatures diagnostic for GvHD. This marker may allow distinguishing active GvHD from irreversible end organ damage and other clinical conditions commonly observed after transplant.
The aim of this study is to evaluate if diagnostic and therapeutic decisions in the clinical management of hepato-intestinal GvHD may be based on the measurement of CK18-F levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: patients following allo-SCT | – | –Patients scheduled for allo-SCT fulfilling all inclusion criteria |
| Group B - healthy controls | – | –healthy voluntary blood donors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for allo-SCT
Key inclusion criteria (10 listed)
- admission for allogenic SCT
- age >= 18 years
- ability of subject to understand character and individual consequences of this clinical trial
- written informed consent
- healthy male of female
Key exclusion criteria (7 listed)
- no specific exclusion criteria
- prolonged bleeding, hemorrhagic diathesis or other indications for clotting disorders in the medical history
- prolonged or intense menses in females
- any other current medical condition or previous disease which in the opinion of investigator may influence subject safety or interfere with the study objective
- intake of any study drug
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
Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F
Time frame: Group A: after allo-SCT for 1 years or until GvHD occures
3 secondary outcomes
Response to therapy
Time frame: 3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD
other serum markers such as sCD25, sCD40L, sFASL, sFAS, cytochrome C, sCD141 correlate with the achievement of complete responses
Time frame: after allo-SCT for 1 year or until GvHD occurres
CK18-F levels in the absence of a clinically diagnosed GvHD
Time frame: after allo-SCT for one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
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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.
Thomas Luft, MD principal investigator
Heidelberg University
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 Allo-SCT, run by Heidelberg University at 1 site in Germany.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Jul 2009. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Luft, MD (+49(0)6221142 ext. 3349, Thomas.Luft@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F (time frame: Group A: after allo-SCT for 1 years or until GvHD occures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2009.