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NCT Number: NCT02821949

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. PCT value performed just before the first chemotherapy treatment

    Time frame: Day 1

    Sampling at the first chemotherapy and each infection

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: KBPCT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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