Autoimmune DiseasesCIADNCT04805099
Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease
An observational study of Autoimmune Diseases and Checkpoint Inhibitor, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial summary
Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Checkpoint Inhibitor, Immunotherapy
- What is being tested?
- Checkpoint inhibitor
- How many people
- 126 participants
- Where
- 1 siteGreece
- Study dates
- 1 Nov 2020to 28 Feb 2021
- 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 diverse tumor types (early-stage or metastatic) who had received checkpoint inhibitors at HeCOG-affiliated Departments of Oncology Eligible patients had a history of AID, and had received treatment with checkpoint inhibitors as any of line of treatment
Who may be able to join
- 18 years or older
- Patients with cancer
- Patients with autoimmune disease
- Treated at HeCOG-affiliated Departments of Oncology
- Early-stage or metastatic
Who cannot join
- diagnosis of the autoimmune disease after initiation of immunotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group
Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).
- Conditions
- Autoimmune Diseases, Checkpoint Inhibitor, Immunotherapy
- Being tested
- Checkpoint inhibitor
- 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 inhibitorDrug
Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: Through the completion of the study, for an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Nov 2020
- Primary completion30 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805099
- Sponsor's protocol ID
- AutoImmune2021
- Acronym
- CIAD
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fountzilas E, Lampaki S, Koliou GA, Koumarianou A, Levva S, Vagionas A, Christopoulou A, Laloysis A, Psyrri A, Binas I, Mountzios G, Kentepozidis N, Kotsakis A, Saloustros E, Boutis A, Nikolaidi A, Fountzilas G, Georgoulias V, Chrysanthidis M, Kotteas E, Vo H, Tsiatas M, Res E, Linardou H, Daoussis D, Bompolaki I, Andreadou A, Papaxoinis G, Spyratos D, Gogas H, Syrigos KN, Bafaloukos D. Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group. Cancer Immunol Immunother. 2022 Feb;71(2):327-337. doi: 10.1007/s00262-021-02985-6. Epub 2021 Jun 23.
PubMed 34164709
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Safety and Efficacy Data of Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease: the Experience of the Hellenic Cooperative Oncology Group
- ClinicalTrials.gov ID
- NCT04805099
- Acronym / sponsor ID
- CIAD / AutoImmune2021
- Conditions
- Autoimmune Diseases, Checkpoint Inhibitor, Immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 18 Mar 2021 (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.
Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).
Study design
- Observational model
- Case only
- 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 diverse tumor types (early-stage or metastatic) who had received checkpoint inhibitors at HeCOG-affiliated Departments of Oncology Eligible patients had a history of AID, and had received treatment with checkpoint inhibitors as any of line of treatment
Key inclusion criteria (5 listed)
- 18 years or older
- Patients with cancer
- Patients with autoimmune disease
- Treated at HeCOG-affiliated Departments of Oncology
- Early-stage or metastatic
Key exclusion criteria (1 listed)
- diagnosis of the autoimmune disease after initiation of immunotherapy
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 inhibitorTreatment with checkpoint inhibitors in patients with preexisting autoimmune disease | Drug | – |
Primary outcome
progression-free survival
Time frame: Through the completion of the study, for an average of 6 months
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 Mar 2021.
- Derived from this study: PubMed 34164709Fountzilas E, Lampaki S, Koliou GA, Koumarianou A, Levva S, Vagionas A, Christopoulou A, Laloysis A, Psyrri A, Binas I, Mountzios G, Kentepozidis N, Kotsakis A, Saloustros E, Boutis A, Nikolaidi A, Fountzilas G, Georgoulias V, Chrysanthidis M, Kotteas E, Vo H, Tsiatas M, Res E, Linardou H, Daoussis D, Bompolaki I, Andreadou A, Papaxoinis G, Spyratos D, Gogas H, Syrigos KN, Bafaloukos D. Real-world safety and efficacy data of immunotherapy in patients with cancer and autoimmune disease: the experience of the Hellenic Cooperative Oncology Group. Cancer Immunol Immunother. 2022 Feb;71(2):327-337. doi: 10.1007/s00262-021-02985-6. Epub 2021 Jun 23.
- 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 Autoimmune Diseases and Checkpoint Inhibitor, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
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 5 inclusion and 1 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 Mar 2021. 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 Greece. 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?
progression-free survival (time frame: Through the completion of the study, for an average of 6 months). 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 NCT04805099, which also lists 1 linked publication.
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 Mar 2021.