Immune Checkpoint InhibitorNCT05675111
Immune Checkpoint Inhibitors(ICPis)-Induced Endocrine Immune-related Adverse Events (irAEs)
An observational study of Immune Checkpoint Inhibitor and Endocrine Toxicity, run by Nanjing Medical University at 1 site in China.
Trial summary
Immune checkpoint inhibitor (ICI) includes agents that block cytotoxic T-cell-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1), and programmed cell death protein ligand 1 (PD-L1). Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Immune Checkpoint Inhibitor, Endocrine Toxicity
- How many people
- 12,408 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 30 Oct 2022
- 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 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older, with cancers who received one dose or more of PD-1/PD-L1 inhibitors 5 academic centers from June 2018 to March 2021 were included.
Who may be able to join
- Cancer patients who received one dose or more of PD-1/PD-L1 inhibitors
Who cannot join
- Insufficient reported details
- Patients younger than 18 years old
- in a double-blind study where treatment allocation cannot be resolved
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Endocrine-related Adverse Events Caused by Immune Checkpoint Inhibitors
Immune checkpoint inhibitor (ICI) includes agents that block cytotoxic T-cell-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1), and programmed cell death protein ligand 1 (PD-L1). Since the FDA-approval of the CTLA-4 inhibitor ipilimumab in 2011, ICI drugs have emerged as a powerful new tool in the treatment for several advanced cancers. Now indications for ICI have expanded dramatically due to their efficacy and include a wide array of cancer types. However, the administration of ICI, whereas, carry the risk of developing immune-related adverse events (irAEs) and may lead to serious and even fatal events. Endocrine dysfunctions are among the most common irAEs that have been reported in clinical trials with ICI, including thyroid dysfunction, hypopituitarism, primary adrenal insufficiency (PAI) and insulin-deficient diabetes (ICI-DM). However, it is difficult to acquire a complete picture of irAEs from randomized controlled trials (RCTs) due to limitations in the study design and realistic practicalities.
- Conditions
- Immune Checkpoint Inhibitor, Endocrine Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nanjing | The First Affiliated Hospital of Nanjing Medical University | |
| Zhengzhou | Henan Provincial People's Hospital | |
| Qingdao | The Affiliated Hospital of Qingdao University | |
| Urumqi | People' s Hospital of Xinjiang Uygur Autonomous Region | |
| Jinan | Shandong Provincial Hospital Affiliated to Shandong First Medical University |
What is being measured
The primary outcome is the main question the study is designed to answer.
irAEs
Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jun 2018
- Primary completion31 Mar 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint InhibitorStudies 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
- Retrospective
- Enrolment
- 12,408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Tao, Nanjing Medical University
- Investigators
- Tao Yang, MD/PhD, Study chair, First Affiliated Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675111
- Sponsor's protocol ID
- 2020-SR-544.A1
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine-related Adverse Events Caused by Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT05675111
- Acronym / sponsor ID
- 2020-SR-544.A1
- Conditions
- Immune Checkpoint Inhibitor, Endocrine Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,408 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 9 Jan 2023 (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.
Immune checkpoint inhibitor (ICI) includes agents that block cytotoxic T-cell-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1), and programmed cell death protein ligand 1 (PD-L1). Since the FDA-approval of the CTLA-4 inhibitor ipilimumab in 2011, ICI drugs have emerged as a powerful new tool in the treatment for several advanced cancers. Now indications for ICI have expanded dramatically due to their efficacy and include a wide array of cancer types. However, the administration of ICI, whereas, carry the risk of developing immune-related adverse events (irAEs) and may lead to serious and even fatal events. Endocrine dysfunctions are among the most common irAEs that have been reported in clinical trials with ICI, including thyroid dysfunction, hypopituitarism, primary adrenal insufficiency (PAI) and insulin-deficient diabetes (ICI-DM). However, it is difficult to acquire a complete picture of irAEs from randomized controlled trials (RCTs) due to limitations in the study design and realistic practicalities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nanjing | – | –The First Affiliated Hospital of Nanjing Medical University |
| Zhengzhou | – | –Henan Provincial People's Hospital |
| Qingdao | – | –The Affiliated Hospital of Qingdao University |
| Urumqi | – | –People' s Hospital of Xinjiang Uygur Autonomous Region |
| Jinan | – | –Shandong Provincial Hospital Affiliated to Shandong First Medical University |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older, with cancers who received one dose or more of PD-1/PD-L1 inhibitors 5 academic centers from June 2018 to March 2021 were included.
Key inclusion criteria (1 listed)
- Cancer patients who received one dose or more of PD-1/PD-L1 inhibitors
Key exclusion criteria (3 listed)
- Insufficient reported details
- Patients younger than 18 years old
- in a double-blind study where treatment allocation cannot be resolved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
irAEs
Time frame: through study completion, an average of 2 year
Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events
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 9 Jan 2023.
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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.
Tao Yang, MD/PhD study chair
First Affiliated Hospital, Nanjing Medical University
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 and Endocrine Toxicity, run by Nanjing Medical University 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 1 inclusion and 3 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 9 Jan 2023. 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?
irAEs (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2023.