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

Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cells Lung Cancer
• Intervention / Treatment: Biological: PCT dosage

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Claire ANDREJAK, MD, PhD; Phone Number: +33 3 22 08 78 93; Email: andrejak.claire@chu-amiens.fr
• Study Contact Backup: Name: Marcellin BELLONET; Phone Number: +33 322668060; Email: bellonet.marcellin@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens
    • Contact: Claire ANDREJAK, MD, PhD; Phone Number: +33 3 22 08 78 93; Email: andrejak.claire@chu-amiens.fr
    • Contact: Marcellin BELLONET; Phone Number: +33 3 22 66 80 60; Email: bellonet.marcellin@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients suffering from a stage 4 NSCLC

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with Non Small Cells Lung Cancer PCT dosage	Biological: PCT dosage; When connecting chemotherapy products, a PCT dosage will be made. The results of dosage won't be communicated to the clinician responsible for the patient. Patient's care will then be identical to any other chemotherapy treated patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCT value performed just before the first chemotherapy treatment	Sampling at the first chemotherapy and each infection	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Claire ANDREJAK, MD, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Estimate): July 4, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Procalcitonin; Non Small Cells Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PI2014_843_0012