Immune Checkpoint Inhibitor-Induced DermatitisNCT06522048
SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) vs. Non-ICIs
An observational study of Immune Checkpoint Inhibitor-Induced Dermatitis and Stevens-Johnson Syndrome, Drug-Induced, run by Chao Ji at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immune Checkpoint Inhibitor-Induced Dermatitis, Stevens-Johnson Syndrome, Drug-Induced, Toxic Epidermal Necrolysis Due to Drug
- What is being tested?
- Observational studies do not require intervention
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to May 2024
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Detailed patient records for SJS/TEN were available in the dermatology inpatient department according to inclusion criteria.
Who may be able to join
- Clinical diagnosis of SJS/TEN induced by any drugs
- Have the immune-related cutaneous adverse events
Who cannot join
- Incomplete medical records
- Unknown the specific culprit drugs
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350000
About this study
Official title: SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) Versus Non-ICIs in Chinese Patients
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 types of drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.
Read the detailed description
Introduction:
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
- Immune Checkpoint Inhibitor-Induced Dermatitis, Stevens-Johnson Syndrome, Drug-Induced, Toxic Epidermal Necrolysis Due to Drug
- Being tested
- Observational studies do not require intervention
- Medical subject headings
- Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studies do not require interventionOther
This is an observational retrospective study and does not require any intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Observational studies do not require intervention | |
| Immune checkpoint inhibitor (ICIs) group | Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by immune checkpoint inhibitor (ICIs) Receives: Other: Observational studies do not require intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications
Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.
Measured: January 2015 to May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study startJan 2015
- Primary completionMay 2024
- Study completionMay 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Immune Checkpoint Inhibitor-Induced DermatitisStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 300 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chao Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chao Ji, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522048
- Sponsor's protocol ID
- Ethical Number [2021]261
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21358399Brahmer 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.
PubMed 29442540Zimmermann 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.
PubMed 28329382Van 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.
PubMed 32158624Lin 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.
PubMed 32154748
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SJS/TEN or Other Cutaneous Adverse Eevents Induced by Immune Checkpoint Inhibitors (ICIs) Versus Non-ICIs in Chinese Patients
- ClinicalTrials.gov ID
- NCT06522048
- Acronym / sponsor ID
- Ethical Number [2021]261
- Conditions
- Immune Checkpoint Inhibitor-Induced Dermatitis, Stevens-Johnson Syndrome, Drug-Induced, Toxic Epidermal Necrolysis Due to Drug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chao JiUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2024 (actual)
- Study completion
- May 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- 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.
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 types of drugs. We analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.
Detailed description
Introduction:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-immune checkpoint inhibitor (non-ICI) drugs group | – | Other: Observational studies do not require interventionStevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by non-immune checkpoint inhibitor (non-ICI) drugs |
| Immune checkpoint inhibitor (ICIs) group | – | Other: Observational studies do not require interventionStevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) induced by immune checkpoint inhibitor (ICIs) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Detailed patient records for SJS/TEN were available in the dermatology inpatient department according to inclusion criteria.
Key inclusion criteria (2 listed)
- Clinical diagnosis of SJS/TEN induced by any drugs
- Have the immune-related cutaneous adverse events
Key exclusion criteria (2 listed)
- Incomplete medical records
- Unknown the specific culprit drugs
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 |
|---|---|---|
| Observational studies do not require interventionThis is an observational retrospective study and does not require any intervention. | Other | Immune checkpoint inhibitor (ICIs) group, Non-immune checkpoint inhibitor (non-ICI) drugs group |
Primary outcome
Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications
Time frame: January 2015 to May 2024
Present the analysis results, highlighting significant differences between the two groups. Use tables and graphs to illustrate key findings.
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 29 Jul 2024.
- Background: PubMed 21358399Gerull 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.
- Background: PubMed 29442540Brahmer 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.
- Background: PubMed 28329382Zimmermann 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.
- Background: PubMed 32158624Van 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.
- Background: PubMed 32154748Lin 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immune Checkpoint Inhibitor-Induced Dermatitis and Stevens-Johnson Syndrome, Drug-Induced, run by Chao Ji at 1 site in China.
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 2 inclusion and 2 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 29 Jul 2024. 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 China. 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?
Analysis of Clinical Features of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitors Versus Non-Immune Checkpoint Inhibitors Medications (time frame: January 2015 to May 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06522048, which also lists 5 linked publications.
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 29 Jul 2024.