Clinical trial NCT02821949: Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung Cancer in First Line Chemotherapy
Official title: Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cells Lung Cancer
Keywords: Non Small Cells Lung Cancer
Procalcitonin
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suffering from a stage 4 NSCLC

Brief summary: Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to check clinically, biologically and radiologically absence of infection. This biological evaluation is based on the CRP rate. Lots of infections may occur in this situation and could reduce by three the patient's life duration. However it is very important to make as early as possible a correct diagnosis of infection. CRP rate is classically higher for those patients even without any infection. In comparison with CRP, Procalcitonin (PCT) is well-known for its better sensibility and specificity for the infection diagnosis but has never been study in case of active cancer. The aim of this study is to evaluate the Procalcitonin basal rate for those patients suffering from NSCLC. It could be a simple and reliable method to use. So the investigators decided to include each new patient with NSCLC stage IV coming for his first-line chemotherapy without any infection sign, and to realize a Procalcitonin dosage before the start of the treatment. This sample will be analyzed at the chemical laboratory and the result will not be communicated to the patient physician. A new clinical evaluation will be realized either at the hospital or by phone at day 7 to search any sign of infection. In absence of infection, patient will be reevaluated at day 14, 21 and 30. In case of infection, a new Procalcitonin (and CRP) dosage will be performed.


Eligibility criteria: Inclusion Criteria:

* Patient with stage IV NSCLC, hospitalized for his first seance of chemotherapy
* Medical conditions permitting chemotherapy
* Informed consent signed
* Patient covered by social insurance

Exclusion Criteria:

* Patient with small cell lung cancer
* Patients with NSCLC stage I, II or III of the Tumor Node Metastasis classification
* Patient with stage IV NSCLC, who received prior treatment (radiotherapy, chemotherapy ...)
* Patient with infection (on clinical and paraclinical criteria) not compatible with the administration of the first seance of chemotherapy.
* Pregnant or breastfeeding women Private Patient freedom or in a position to judicial protection (guardianship)

Primary outcomes:
measure: PCT value performed just before the first chemotherapy treatment
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Claire ANDREJAK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: