Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung Cancer in Fi… (NCT02821949) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung Cancer in First Line Chemotherapy
France45 participantsStarted 2014-12-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was measuring procalcitonin (PCT) levels in people with stage IV non-small cell lung cancer before starting chemotherapy — what is procalcitonin, and why might my doctor want to track that marker during my treatment?
2Since this study has already completed, has my doctor seen any of its findings, and do the results suggest PCT levels could help predict anything meaningful about how first-line chemotherapy might go for someone in my situation?
3This trial focused specifically on stage IV non-small cell lung cancer — given that my diagnosis and staging may or may not match that exactly, would my doctor consider monitoring PCT as part of managing my care?
4Because this was a measurement or observational study rather than a treatment trial, it wasn't testing a new drug — so how does following a study like this compare to exploring trials that are actually testing new therapies for my stage of lung cancer?
5If elevated PCT can signal infection or inflammation, is there anything about starting first-line chemotherapy that makes tracking infection-related markers like this especially important for me to discuss with my care team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PCT value performed just before the first chemotherapy treatment