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

NCT ID: NCT02821949

Last Updated: 2016-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Non Small Cells Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with Non Small Cells Lung Cancer PCT dosage

PCT dosage

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire ANDREJAK, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire ANDREJAK, MD, PhD

Role: CONTACT

+33 3 22 08 78 93

Marcellin BELLONET

Role: CONTACT

322668060 ext. +33

Facility Contacts

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Claire ANDREJAK, MD, PhD

Role: primary

+33 3 22 08 78 93

Marcellin BELLONET

Role: backup

+33 3 22 66 80 60

Other Identifiers

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PI2014_843_0012

Identifier Type: -

Identifier Source: org_study_id

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