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

NCT02821949 | Unknown

• 1 other identifier: PI2014_843_0012
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cells Lung Cancer

Keywords

Non Small Cells Lung Cancer; Procalcitonin

Outcome Measures

Primary Outcomes (1)

• PCT value performed just before the first chemotherapy treatment

  Sampling at the first chemotherapy and each infection

  Day 1

Study Arms (1)

Patients

Patients with Non Small Cells Lung Cancer PCT dosage

Biological: PCT dosage

Interventions

PCT dosage BIOLOGICAL

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients suffering from a stage 4 NSCLC

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

Study Officials

• Claire ANDREJAK, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire ANDREJAK, MD, PhD

CONTACT

+33 3 22 08 78 93; andrejak.claire@chu-amiens.fr

Marcellin BELLONET

CONTACT

322668060; bellonet.marcellin@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: July 4, 2016
• Study Start: December 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 4, 2016

Record last verified: 2016-06

Locations

FR (1)