Procalcitonin as a Marker of Infection in Cancer Patients
NCT ID: NCT01227109
Last Updated: 2010-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2011-02-28
2012-10-31
Brief Summary
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This study examines procalcitonin as a potential marker of bacterial infection in cancer patients.
Detailed Description
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Is pro calcitonin a marker for bacterial infection in cancer patients? Is pro calcitonin better than C-reactive-protein to identify cancer patients with a bacterial infection?
Background:
Infections, in particular bacterial, pose a major threat to cancer patients as treatment related immuno-suppression and general weakness increase risk and severity of infections. Prompt identification of patients with a bacterial infection is necessary. Traditionally, fever, leucocytosis and elevated c-reactive protein (CRP) have been used in the evaluation in patients with suspected infection. How-ever, fever may be reduced by analgesics and steroids, leucocytes may be decreased due to anticancer therapy and CRP is in some cases elevated by the cancer disease as such. The diagnosis of bacterial infection is thus more difficult in cancer patients. Recently, pro-calcitonin (PCT) (her dækker maja's godt)
Design of the study:
Two groups will be included in this study:
Group I includes patients in anti-cancer therapy including chemo and radiotherapy, targeted treatment and radiotherapy but not hormone treatment, and without any sign of infection defined as temperature \< 38 C and no focal symptoms of infections. Vital signs are noted and blood tests for haematology, CPR and PCT are drawn. Details about cancer type, stage, treatment history of infections less than 1 month prior and co-morbidity are registered. Data from this cohort will be used to assess median CRP and PCT among non-infected cancer patients. Forty patients will be included.
Group II includes patients in anti-cancer therapy including chemo and radiotherapy, targeted treatment and radiotherapy but not hormone treatment, who is hospitalized with suspected infection (temp\> 38 last 24 hours). At the time of hospitalization, vital signs are noted and blood tests for haematology, CPR and PCT are drawn. Details about cancer type, stage, treatment history of infections less than 1 month prior and co-morbidity are registered. All hospitals records are reviewed after discharge to determine if a certain diagnosis of infection (positive bacteriology), probable infection (negative bacteriology but clinical course consistent with bacterial infection) or non infection was made. Data from this cohort will be used to assess the role of CRP and PCT in prediction of bacterial infection. Forty patients will be included in this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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With infection
This group consist of cancer patients with a bacterial infection
No interventions assigned to this group
Without infection
This is a group of cancer patients without infection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Both groups: Informed consent
Exclusion Criteria
\-
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Herlev Hospital
OTHER
Responsible Party
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Herlev University Hospital
Locations
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Herlev University Hospital
Copenhagen, , Denmark
Herlev hospital
Herlev, , Denmark
Countries
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Central Contacts
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References
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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.
Other Identifiers
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Procalcitonin-one
Identifier Type: -
Identifier Source: org_study_id