Procalcitonin as a Marker of Infection in Cancer Patients
1 other identifier
observational
80
1 country
2
Brief Summary
Infections pose a serious threat to cancer patients in chemotherapy. Prompt diagnosis and treatment is of paramount importance as infections may be life-threatening in immune-compromised individuals. Traditionally, the C-reactive protein (CRP) has been used as a marker of infection. However, the CRP is also often elevated in cancer patients and as a marker CRP may be unreliable in cancer patients. Other markers for infection includes procalcitonin which has been showed to be of some value for the diagnose of bacterial infections. This study examines procalcitonin as a potential marker of bacterial infection in cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 25, 2010
October 1, 2010
1 year
October 22, 2010
October 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of procalcitonin elevation in cancer patients with or with out infection
The mean procalcitonin value will be compared between two groups of cancer patients with and with-out infections respectively.
less than 60 days
Study Arms (2)
With infection
This group consist of cancer patients with a bacterial infection
Without infection
This is a group of cancer patients without infection
Eligibility Criteria
Two groups of 40 patiens each, one with bacterial infection, the other without any signs or symptoms of infection
You may qualify if:
- Gr I: In-patients in anticancer therapy for a solid cancer with confirmed bacterial infection Gr II: Patients in anticancer therapy without any signs or symptoms of infection.
- Both groups: Informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
- Rigshospitalet, Denmarkcollaborator
Study Sites (2)
Herlev University Hospital
Copenhagen, DK-2730 Herlev, Denmark
Herlev hospital
Herlev, dk-2730, Denmark
Related Publications (1)
Diness LV, Maraldo MV, Mortensen CE, Mellemgaard A, Larsen FO. Procalcitonin and C-reactive protein as markers of bacterial infection in patients with solid tumours. Dan Med J. 2014 Dec;61(12):A4984.
PMID: 25441735DERIVED
Biospecimen
Blood will be drawn for CRP and procalcitonin analysis
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 25, 2010
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
October 1, 2012
Last Updated
October 25, 2010
Record last verified: 2010-10