Procalcitonin as a Marker of Infection in Cancer Patients

Sponsor

Herlev Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01227109

Collaborator

Rigshospitalet, Denmark (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Procalcitonin as a Marker of Infection in Cancer Patients

Study Start Date :

Feb 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2012

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
With infection This group consist of cancer patients with a bacterial infection
Without infection This is a group of cancer patients without infection

Outcome Measures

Primary Outcome Measures

Frequency of procalcitonin elevation in cancer patients with or with out infection [less than 60 days]
The mean procalcitonin value will be compared between two groups of cancer patients with and with-out infections respectively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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