Procalcitonin as a Marker of Infection in Cancer Patients

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.

Study Overview

• Status: Unknown
• Conditions: Infections; Cancer; Procalcitonin; C Reactive Protein

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: anders mellemgaard, MD PhD; Phone Number: +45 38682891; Email: andmel01@heh.regionh.dk
• Study Contact Backup: Name: ole larsen, MD PhD; Phone Number: +45 38682329; Email: olelar02@heh.regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2730 Herlev
    • Herlev University Hospital
  • Herlev, Denmark, DK-2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Two groups of 40 patiens each, one with bacterial infection, the other without any signs or symptoms of infection

Description

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

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
With infection; This group consist of cancer patients with a bacterial infection
Without infection; This is a group of cancer patients without infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Cancer; Procalcitonin; Infections; C reactive protein
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: Procalcitonin-one