NCT01227109

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 25, 2010

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

October 22, 2010

Last Update Submit

October 22, 2010

Conditions

Keywords

InfectionsCancerProcalcitoninC reactive protein

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

With infection

This group consist of cancer patients with a bacterial infection

Without infection

This is a group of cancer patients without infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herlev University Hospital

Copenhagen, DK-2730 Herlev, Denmark

Location

Herlev hospital

Herlev, dk-2730, Denmark

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be drawn for CRP and procalcitonin analysis

MeSH Terms

Conditions

InfectionsNeoplasms

Central Study Contacts

anders mellemgaard, MD PhD

CONTACT

ole larsen, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

October 1, 2012

Last Updated

October 25, 2010

Record last verified: 2010-10

Locations