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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
Sponsor:
Information provided by (Responsible Party):
Alexandre Niset, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NSCLC's patients

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).




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cliniques Universitaires Saint-Luc's patients with NSCLC eligible and treated with immunotherapy.
Criteria

Inclusion Criteria:

  • Any patient with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy in first or second line.

Exclusion Criteria:

  • The refusal to sign the consent.

Information from the National Library of Medicine

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


Contacts
Contact: Thierry Pieters, MD, PhD +3227642833 thierry.pieters@uclouvain.be
Contact: Alexandre Niset, Student +32495539059 alexandre.niset@student.uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Thierry Pieters, MD, PhD    +3227642833    thierry.pieters@uclouvain.be   
Contact: Alexandre Niset, Student    +32495539059    alexandre.niset@student.uclouvain.be   
Principal Investigator: Thierry Pieters, MD, PhD         
Principal Investigator: Alexandre Niset, Student         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Study Director: Thierry Pieters, MD, PhD Cliniques universitaires Saint-Luc

Publications of Results:

Responsible Party: Alexandre Niset, Med student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03125603     History of Changes
Other Study ID Numbers: 2017/15MAR/137
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alexandre Niset, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Immunotherapy
Anti-PD-(L)-1
Anti-CTLA-4

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Drug-Related Side Effects and Adverse Reactions
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders