Procalcitonin as a Marker of Infection in Cancer Patients

Cancer Clinical Trial

Official title:

Procalcitonin as a Marker of Infection in Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01227109
• Other study ID #: Procalcitonin-one
• Status: Not yet recruiting
• Phase: N/A
• First received: October 22, 2010
• Last updated: October 22, 2010
• Start date: February 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2010
• Source: Herlev Hospital
• Contact: anders mellemgaard, MD PhD
• Phone: +45 38682891
• Email: andmel01[@]heh.regionh.dk
• Is FDA regulated: No
• Health authority: Ethics Committee Denmark:Region Hovedstaden - Kongens Vænge 2 - 3400 Hillerød - Denmark:
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• C Reactive Protein
• Cancer
• Communicable Diseases
• Infection
• Infections
• Procalcitonin

Locations

Country	Name	City	State
Denmark	Herlev University Hospital	Copenhagen
Denmark	Herlev hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No