SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs
NCT ID: NCT06522048
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
300 participants
OBSERVATIONAL
2015-01-31
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
NCT06474078
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
NCT01276314
Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
NCT03585946
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
NCT06119490
Skin Cancer in Swiss Transplant Cohort Study
NCT02361229
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a severe adverse drug reaction characterized by extensive skin detachment. With the increasing use of immune checkpoint inhibitors (ICIs) in oncology, it is crucial to understand the differences in SJS/TEN induced by ICIs compared to other drugs. This study aims to compare the clinical manifestations and outcomes of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (ICIs) versus other type drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.
Methods:
* Study Design: Retrospective cohort study or cross-sectional study.
* Participants: 60 patients with ICI-induced SJS/TEN and 100 to 500 patients with other drug-induced SJS/TEN.
* Data Collection: Detailed medical records were reviewed to extract information.
* Statistical Analysis: analysis using appropriate statistical tests (e.g., t-test, chi-square test).
Results:
Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.
Conclusion:
We discuss the clinical implications of the findings, potential mechanisms underlying the observed differences, and the relevance to patient management. Summarize the main findings and their significance for clinical practice. Emphasize the need for tailored treatment approaches based on the type of drug causing SJS/TEN.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-immune checkpoint inhibitor (non-ICI) drugs group
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by non-immune checkpoint inhibitor (non-ICI) drugs
Observational studies do not require intervention
This is an observational retrospective study and does not require any intervention.
Immune checkpoint inhibitor (ICIs) group
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by immune checkpoint inhibitor (ICIs)
Observational studies do not require intervention
This is an observational retrospective study and does not require any intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Observational studies do not require intervention
This is an observational retrospective study and does not require any intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have the immune-related cutaneous adverse events
Exclusion Criteria
* Unknown the specific culprit drugs
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chao Ji
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chao Ji
Vice President of the Dermatology Branch of the First Affiliated Hospital of Fujian Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gerull R, Nelle M, Schaible T. Toxic epidermal necrolysis and Stevens-Johnson syndrome: a review. Crit Care Med. 2011 Jun;39(6):1521-32. doi: 10.1097/CCM.0b013e31821201ed.
Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA; National Comprehensive Cancer Network. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018 Jun 10;36(17):1714-1768. doi: 10.1200/JCO.2017.77.6385. Epub 2018 Feb 14.
Zimmermann S, Sekula P, Venhoff M, Motschall E, Knaus J, Schumacher M, Mockenhaupt M. Systemic Immunomodulating Therapies for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017 Jun 1;153(6):514-522. doi: 10.1001/jamadermatol.2016.5668.
Van Wilpe S, Koornstra R, Den Brok M, De Groot JW, Blank C, De Vries J, Gerritsen W, Mehra N. Lactate dehydrogenase: a marker of diminished antitumor immunity. Oncoimmunology. 2020 Feb 26;9(1):1731942. doi: 10.1080/2162402X.2020.1731942. eCollection 2020.
Lin CC, Chen CB, Wang CW, Hung SI, Chung WH. Stevens-Johnson syndrome and toxic epidermal necrolysis: risk factors, causality assessment and potential prevention strategies. Expert Rev Clin Immunol. 2020 Apr;16(4):373-387. doi: 10.1080/1744666X.2020.1740591. Epub 2020 Apr 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ethical Number [2021]261
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.