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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02821949
Acronym
KBPCT
Enrollment
45
Registered
2016-07-04
Start date
2014-12-23
Completion date
2017-12-27
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cells Lung Cancer

Keywords

Non Small Cells Lung Cancer, Procalcitonin

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.

Interventions

BIOLOGICALPCT 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
PCT value performed just before the first chemotherapy treatmentDay 1Sampling at the first chemotherapy and each infection

Countries

France

Contacts

PRINCIPAL_INVESTIGATORClaire ANDREJAK, MD, PhD

CHU Amiens

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026