Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung Cancer in First Line Chemotherapy

• Conditions: Non Small Cells Lung Cancer
• Interventions: Biological: PCT dosage

• Registration Number: NCT02821949
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-04-10
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Study First Posted: 2016-07-04
• Last Update Posted: 2016-07-04
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	PCT dosage	Patients with Non Small Cells Lung Cancer PCT dosage

Primary Outcome Measures

Name	Time	Method
PCT value performed just before the first chemotherapy treatment	Day 1	Sampling at the first chemotherapy and each infection

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France