CancerNCT00179868
C-Reactive Protein as a Predictor of Stem Cell Transplant Complications
An observational study of Cancer and Leukemia, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine if C-Reactive Protein levels are predictive for complications post transplant. Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- Cancer, Leukemia, Stem Cell Transplantation
- What is being tested?
- C-Reactive Protein levels
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Feb 2008
- 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 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing a stem cell transplant
Who may be able to join
- Age 6 months to 20 years
- Patient undergoing a stem cell transplant (allogeneic, syngeneic, or autologous) at Childrens' Memorial Hospital
- IRB approved informed consent (and assent for children age 12-17)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hospital
Chicago, Illinois, 60614
About this study
Official title: C-Reactive Protein As a Predictor of Major Transplant Complications in Pediatric Stem Cell Transplant Patients
The purpose of this study is to determine if C-Reactive Protein levels are predictive for complications post transplant.
- Conditions
- Cancer, Leukemia, Stem Cell Transplantation
- Being tested
- C-Reactive Protein levels
- Keywords
- cancer, leukemia, stem cell transplant, complications
- Medical subject headings
- Neoplasms, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Reactive Protein levelsBehavioural
Each patient enrolled in the study will have a serum quantitative c-reactive protein (crp) level drawn on the day of transplant, day 7 of transplant, and twice weekly after that until recovery of neutrophil count (approximately 20-25 days). Patients will be followed for 100 days post-transplant for the development of the following complications:
- Sepsis- defined as fever, positive blood culture, need for fluid resuscitation and/or pressor support.
- Acute GVHD > grade II defined according to the Seattle criteria
- VOD- defined according to the modified Seattle criteria
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether quantitative c-reactive protein measurements can predict major morbidity and mortality in pediatric stem cell transplant patients.
Measured: To day +100 post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morris Kletzel, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179868
- Sponsor's protocol ID
- SCT 0403 CRP
- Status last verified
- Feb 2025
- First submitted
- 10 Sep 2005
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-Reactive Protein As a Predictor of Major Transplant Complications in Pediatric Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT00179868
- Acronym / sponsor ID
- SCT 0403 CRP
- Conditions
- Cancer, Leukemia, Stem Cell Transplantation
- Keywords
- cancer, leukemia, stem cell transplant, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to determine if C-Reactive Protein levels are predictive for complications post transplant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing a stem cell transplant
Key inclusion criteria (3 listed)
- Age 6 months to 20 years
- Patient undergoing a stem cell transplant (allogeneic, syngeneic, or autologous) at Childrens' Memorial Hospital
- IRB approved informed consent (and assent for children age 12-17)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Reactive Protein levelsEach patient enrolled in the study will have a serum quantitative c-reactive protein (crp) level drawn on the day of transplant, day 7 of transplant, and twice weekly after that until recovery of neutrophil count (approximately 20-25 days). Patients will be followed for 100 days post-transplant for the development of the following complications: 1. Sepsis- defined as fever, positive blood culture, need for fluid resuscitation and/or pressor support. 2. Acute GVHD > grade II defined according to the Seattle criteria 3. VOD- defined according to the modified Seattle criteria | Behavioural | – |
Primary outcome
To determine whether quantitative c-reactive protein measurements can predict major morbidity and mortality in pediatric stem cell transplant patients.
Time frame: To day +100 post transplant
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 6 Feb 2025.
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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.
Morris Kletzel, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
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 Cancer and Leukemia, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 3 inclusion and 0 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 6 Feb 2025. 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?
To determine whether quantitative c-reactive protein measurements can predict major morbidity and mortality in pediatric stem cell transplant patients. (time frame: To day +100 post transplant). 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 6 Feb 2025.