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Procalcitonin as a Marker of Infection in Cancer Patients

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ClinicalTrials.gov Identifier: NCT01227109
Recruitment Status : Unknown
Verified October 2010 by Herlev Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Herlev Hospital

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
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
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin as a Marker of Infection in Cancer Patients
Study Start Date : February 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : October 2012

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



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


Biospecimen Retention:   Samples Without DNA
Blood will be drawn for CRP and procalcitonin analysis


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227109


Contacts
Contact: anders mellemgaard, MD PhD +45 38682891 andmel01@heh.regionh.dk
Contact: ole larsen, MD PhD +45 38682329 olelar02@heh.regionh.dk

Locations
Denmark
Herlev University Hospital
Copenhagen, Denmark, DK-2730 Herlev
Herlev hospital
Herlev, Denmark, dk-2730
Sponsors and Collaborators
Herlev Hospital
Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anders Mellemgaard, Herlev University Hospital
ClinicalTrials.gov Identifier: NCT01227109     History of Changes
Other Study ID Numbers: Procalcitonin-one
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by Herlev Hospital:
Infections
Cancer
Procalcitonin
C reactive protein

Additional relevant MeSH terms:
Infection
Communicable Diseases
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs