NCT03350802

Brief Summary

The purpose of this study is to evaluate the usefulness of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
649

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

6.5 years

First QC Date

November 17, 2017

Last Update Submit

September 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Procalcitonin level according to the cause of pneumonia in patients with cancer

    bacterial pneumonia vs. radiation pneumonitis vs chemotherapy-induced pneumonitis

    procalcitonin level is checked within 24hours after visiting hospital

Secondary Outcomes (2)

  • Influence of neutropenia on procalcitonin level in patients with baterial pneumonia

    procalcitonin level is checked within 24hours after visiting hospital

  • procalcitonin level in patients with atypical pneumonia

    procalcitonin level is checked within 24hours after visiting hospital

Study Arms (1)

procalcitonin pneumonia cohort

Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort.

Diagnostic Test: procalcitonin test

Interventions

procalcitonin testDIAGNOSTIC_TEST

All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test.

procalcitonin pneumonia cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort. * suspected symptom: cough, sputum, dyspnea or fever/chill * suspected image findings: consolidation or ground-glass opacity on chest radiograph or CT 2. All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test. * basic microbiological test: blood culture, sputum gram stain/culture, pneumococcal urinary antigen, legionella urinary antigen, mycoplasma antibody etc.

You may qualify if:

  • Age greater than 18 years
  • Patients who have symptoms and suspected imaging findings compatible with pneumonia

You may not qualify if:

  • Patients who have been treated with antibiotics or steroid therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Clinic, National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

PneumoniaNeoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • HEE SEOK LEE, M.D.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pulmonologist

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 22, 2017

Study Start

January 1, 2014

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations