Side Effects of Anti-PD-(L)-1 and Anti CTLA-A4 in the Non Small Cells Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03125603|
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
The immune-related adverse events (irAEs) linked to the important activation of the immune system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma (NSCLC) have not received a lot of systematic study or been monitored over time outside of clinical trials.
This study aims to verify, on the basis of the data collected in a prospective and retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments observed in the target population of the controlled clinical trials are the same as in the general clinical population.
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung Drug-Related Side Effects and Adverse Reactions||Other: Consultation of the patient's medical files at the hospital|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||140 participants|
|Target Follow-Up Duration:||20 Months|
|Official Title:||Census and Follow-up of the Side Effects in the New Immunotherapeutic Treatments Anti-PD-(L)-1 and Anti-CTLA-4 of the Non Small Cells Lung Cancer|
|Actual Study Start Date :||April 13, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Patients with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy.
Consultation of the patient's medical files at the hospital.
Other: Consultation of the patient's medical files at the hospital
Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).
- Census and monitor of the side-effects due to the immunotherapy treatment. [ Time Frame: Through study completion, an average of 20 months. ]Census of the side-effect type, severity according to the CTCAE and monitoring the side-effect's development.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125603
|Contact: Thierry Pieters, MD, PhDemail@example.com|
|Contact: Alexandre Niset, Studentfirstname.lastname@example.org|
|Cliniques Universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, 1200|
|Contact: Thierry Pieters, MD, PhD +3227642833 email@example.com|
|Contact: Alexandre Niset, Student +32495539059 firstname.lastname@example.org|
|Principal Investigator: Thierry Pieters, MD, PhD|
|Principal Investigator: Alexandre Niset, Student|
|Study Director:||Thierry Pieters, MD, PhD||Cliniques universitaires Saint-Luc|