Non Small Cells Lung CancerKBPCTNCT02821949
Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung Cancer in First Line Chemotherapy
An observational study of Non Small Cells Lung Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cells Lung Cancer
- What is being tested?
- PCT dosage
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2014to 27 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from a stage 4 NSCLC
Who may be able to join
- Patient with stage IV NSCLC, hospitalized for his first seance of chemotherapy
- Medical conditions permitting chemotherapy
- Informed consent signed
- Patient covered by social insurance
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Non Small Cells Lung Cancer
- Being tested
- PCT dosage
- Keywords
- Non Small Cells Lung Cancer, Procalcitonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCT dosageBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with Non Small Cells Lung Cancer PCT dosage Receives: Biological: PCT dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCT value performed just before the first chemotherapy treatment
Sampling at the first chemotherapy and each infection
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start23 Dec 2014
- Primary completion27 Dec 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cells Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire ANDREJAK, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821949
- Sponsor's protocol ID
- PI2014_843_0012
- Acronym
- KBPCT
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2015
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung
- ClinicalTrials.gov ID
- NCT02821949
- Acronym / sponsor ID
- KBPCT / PI2014_843_0012
- Conditions
- Non Small Cells Lung Cancer
- Keywords
- Non Small Cells Lung Cancer, Procalcitonin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 23 Dec 2014 (actual)
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: PCT dosagePatients with Non Small Cells Lung Cancer PCT dosage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from a stage 4 NSCLC
Key inclusion criteria (4 listed)
- Patient with stage IV NSCLC, hospitalized for his first seance of chemotherapy
- Medical conditions permitting chemotherapy
- Informed consent signed
- Patient covered by social insurance
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCT dosageWhen 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 | Biological | Patients |
Primary outcome
PCT value performed just before the first chemotherapy treatment
Time frame: Day 1
Sampling at the first chemotherapy and each infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire ANDREJAK, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cells Lung Cancer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCT value performed just before the first chemotherapy treatment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.