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Procalcitonin as a Marker of Infection in Cancer Patients

Procalcitonin as a Marker of Infection in Cancer Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01227109
Enrollment
80
Registered
2010-10-25
Start date
2011-02-28
Completion date
2012-10-31
Last updated
2010-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, C Reactive Protein, Infections, Procalcitonin

Keywords

Infections, Cancer, Procalcitonin, C reactive protein

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.

Detailed description

Purpose of the study: 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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

None \-

Design outcomes

Primary

MeasureTime frameDescription
Frequency of procalcitonin elevation in cancer patients with or with out infectionless than 60 daysThe mean procalcitonin value will be compared between two groups of cancer patients with and with-out infections respectively.

Countries

Denmark

Contacts

Primary Contactanders mellemgaard, MD PhD
andmel01@heh.regionh.dk+45 38682891
Backup Contactole larsen, MD PhD
olelar02@heh.regionh.dk+45 38682329

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026