Autoimmune DiseasesNCT03140137
Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases
An observational study of Autoimmune Diseases and Advanced Cancer, run by University Hospital, Brest at 5 sites in France.
Trial summary
The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Advanced Cancer
- What is being tested?
- Checkpoint inhibitor therapy
- How many people
- 112 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Jan 2017to 4 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a pre-existing autoimmune disease who received immune checkpoint inhibitors for the treatment of an advanced cancer in clinical practice.
Who may be able to join
- Pre-existing autoimmune disease as diagnosed by the physician
- Immune checkpoint inhibitor therapy for an advanced cancer
Who cannot join
- Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy
- Absence of follow-up
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH d'AIX
Aix-en-Provence, 13616
CHU de DIJON
Dijon, 21079
CHD Vendée
La Roche-sur-Yon, 85925
Ch Le Mans
Le Mans, 72000
CH de MACON
Mâcon, 78018
About this study
Official title: Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases
The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.
- Conditions
- Autoimmune Diseases, Advanced Cancer
- Being tested
- Checkpoint inhibitor therapy
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checkpoint inhibitor therapyDrug
Treatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoimmune disease flare
Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Other immune/inflammatory complications
Development of a new immune/inflammatory condition after the start of the therapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start21 Jan 2017
- Primary completion4 Jan 2018
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Divi CORNEC, Study director, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140137
- Sponsor's protocol ID
- CHECKAUTO
- Status last verified
- Apr 2019
- First submitted
- 24 Feb 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT03140137
- Acronym / sponsor ID
- CHECKAUTO
- Conditions
- Autoimmune Diseases, Advanced Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 4 May 2017 (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.
The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a pre-existing autoimmune disease who received immune checkpoint inhibitors for the treatment of an advanced cancer in clinical practice.
Key inclusion criteria (2 listed)
- Pre-existing autoimmune disease as diagnosed by the physician
- Immune checkpoint inhibitor therapy for an advanced cancer
Key exclusion criteria (2 listed)
- Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy
- Absence of follow-up
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 |
|---|---|---|
| Checkpoint inhibitor therapyTreatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice | Drug | – |
Primary outcome
Autoimmune disease flare
Time frame: through study completion, an average of 1 year
Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician
1 secondary outcome
Other immune/inflammatory complications
Time frame: through study completion, an average of 1 year
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 22 Apr 2019.
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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.
Divi CORNEC study director
CHRU de Brest
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases and Advanced Cancer, run by University Hospital, Brest at 5 sites in France.
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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Autoimmune disease flare (time frame: through study completion, an average of 1 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 22 Apr 2019.