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Procalcitonin as a Marker of Infection in Cancer Patients


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N/A
Not Enrolling
Both
Infections, Cancer, Procalcitonin, C Reactive Protein

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Trial Information

Procalcitonin as a Marker of Infection in Cancer Patients


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.


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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Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Frequency of procalcitonin elevation in cancer patients with or with out infection

Outcome Description:

The mean procalcitonin value will be compared between two groups of cancer patients with and with-out infections respectively.

Outcome Time Frame:

less than 60 days

Safety Issue:

No

Authority:

Ethics Committee Denmark:

Study ID:

Procalcitonin-one

NCT ID:

NCT01227109

Start Date:

February 2011

Completion Date:

October 2012

Related Keywords:

  • Infections
  • Cancer
  • Procalcitonin
  • C Reactive Protein
  • Infections
  • Cancer
  • Procalcitonin
  • C reactive protein

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