CancerIMMUCARE-BASENCT03989323
A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
An observational study of Cancer, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Estimation of the incidence of the irAE
- How many people
- 2,000 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Jul 2019to 15 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with cancer and starting anticancer immunotherapy (-immune checkpoint inhibitors: anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new emerging immune checkpoint inhibitors).
Who may be able to join
- Age > 18
- Patient starting anticancer immunotherapy treatment(immune checkpoint inhibitors like anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new anticancer immunotherapy) in monotherapy or associatied with other anticancer molecules.
- Patient who had already received immunotherapy can be eligible to IMMUCARE-BASE provided that the last immunotherapy treatment had been administered > 6 months ago.
- Patient who received written information about IMMUCARE-BASE.
- Patient receiving immunotherapy as a part of a clinical trial can be eligible to IMMUCARE-BASE according to the indications given by the promoter of this trial.
- Patient in a clinical trial which includes a combination of therapy with one of the drugs administered in a blind manner vs placebo, can be eligible to IMMUCARE-BASE provided that (i) the treatment administered in a blind manner is not the immunotherapy and (ii) the clinical trial allows concomitant participation of a patient in another non-interventional study.
- A Patient that has been already included in IMMUCARE-BASE and who terminates the study because of a change of treatment, can be included again in IMMUCARE-BASE if he/she agrees and provided that (i) is the new treatment includes immunotherapy (alone or in association with other anticancer molecules) and (iii) the new immunotherapy treatment is administered after 6 months from the last administration of the previous immunotherapy.
- -Signature of the informed consent.
Who cannot join
- Patient who had received immunotherapy within 6 months before entering in IMMUCARE-BASE
- Minor patient
- Pregnant women
- Patient under juridical protection
- Patient refusal to participate.
- Weight ≤ 50kg
- Haemoglobin < 90g/L at the time of the inclusion
- Patient participating in clinical trials where blood samples are taken for ancillary studies.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Hôpital L. Pradel
Bron
Sara Calattini, PhD
Michael DURUISSEAUX, MD
- Not yet recruiting
Hôpital Pierre Wertheimer
Bron
Sara Calattini, PhD
Jerome HONNORAT, MD
- Not yet recruiting
Hôpital de la Croix Rousse
Lyon
Sara Calattini, PhD
Lize KIAKOUAMA-MALEKA, MD
- Not yet recruiting
Hôpital E Herriot
Lyon
Sara Calattini, PhD
Thomas WALTER, MD
- Recruiting
Centre Hospitalier LYON SUD
Pierre-Bénite
Jonathan LOPEZ, MD, +33 4 78 86 16 07 ext. +33, jonathan.lopez@chu-lyon.fr
Sara CALATTINI, PhD, +33 4.78.86.37.79 ext. +33, sara.calattini@chu-lyon.fr
About this study
The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. The care of patients treated with these molecules require the development of multidisciplinary skills and the introduction of a professional network capable of taking care of immunotherapy related toxicity (irAE) that can affect different organs and for which immediate and effective interventions are necessary for patient survival.
IMMUCARE-BASE will comprehensively enable the collection, of clinical and biological data of patients treated with anticancer immunotherapy. The creation of this database is essential to identify clinico-biological factors predisposing to toxicity, and to define the best strategies to prevent the early onset of irAE and/or to treat them. Ultimately, the objective of this database is to collect enough data to be able to personalise in the future the immunotherapy treatment according to the benefits and to anticipate risks for each patient.
The objective of the biological collection is to perform ancillary studies for understanding mechanism leading to toxicity and for the development of research programs in the field of immunotherapy.
- Conditions
- Cancer
- Being tested
- Estimation of the incidence of the irAE
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimation of the incidence of the irAEOther
Assessment of the incidence of the irAE in patients treated with immunotherapy at the Hospices Civils de Lyon (irAE of all grades and from all organs) and creation of a biological collection of blood, plasma, serum and PBMCs from patients before treatment, under treatment and at the onset of irAEs.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with immunotherapy | Patients receiving for the first time an immunotherapy treatment for their cancer (Checkpoints inhibitors, such as PD-1 or PD-L1 or CTLA4…). Patients will be enrolled before starting the immunotherapy treatment and will be followed up for 5 years or until the permanent discontinuation of the immunotherapy treatment to describe the arm. Receives: Other: Estimation of the incidence of the irAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the incidence of immunotherapy-related toxicities (all grades, of all organs, in real life) in patients treated for the first time with anticancer immunotherapy and enrolled in the "IMMUCARE-BASE" clinical database
Patients can be treated with immunotherapy alone, or in association with other immunotherapies, or association with chemotherapies, targeted therapies or radiotherapy. It will include all types of cancers that can be treated with immunotherapy, also including patients that are in clinical trials.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start15 Jul 2019
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan LOPEZ, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989323
- Sponsor's protocol ID
- 69HCL18_0816
- Acronym
- IMMUCARE-BASE
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2019
- Last updated
- 27 Jul 2021
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
- ClinicalTrials.gov ID
- NCT03989323
- Acronym / sponsor ID
- IMMUCARE-BASE / 69HCL18_0816
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 18 Jun 2019 (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 number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. The care of patients treated with these molecules require the development of multidisciplinary skills and the introduction of a professional network capable of taking care of immunotherapy related toxicity (irAE) that can affect different organs and for which immediate and effective interventions are necessary for patient survival.
IMMUCARE-BASE will comprehensively enable the collection, of clinical and biological data of patients treated with anticancer immunotherapy. The creation of this database is essential to identify clinico-biological factors predisposing to toxicity, and to define the best strategies to prevent the early onset of irAE and/or to treat them. Ultimately, the objective of this database is to collect enough data to be able to personalise in the future the immunotherapy treatment according to the benefits and to anticipate risks for each patient.
The objective of the biological collection is to perform ancillary studies for understanding mechanism leading to toxicity and for the development of research programs in the field of immunotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with immunotherapy | – | Other: Estimation of the incidence of the irAEPatients receiving for the first time an immunotherapy treatment for their cancer (Checkpoints inhibitors, such as PD-1 or PD-L1 or CTLA4…). Patients will be enrolled before starting the immunotherapy treatment and will be followed up for 5 years or until the permanent discontinuation of the immunotherapy treatment to describe the arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cancer and starting anticancer immunotherapy (-immune checkpoint inhibitors: anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new emerging immune checkpoint inhibitors).
Key inclusion criteria (8 listed)
- Age > 18
- Patient starting anticancer immunotherapy treatment(immune checkpoint inhibitors like anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new anticancer immunotherapy) in monotherapy or associatied with other anticancer molecules.
- Patient who had already received immunotherapy can be eligible to IMMUCARE-BASE provided that the last immunotherapy treatment had been administered > 6 months ago.
- Patient who received written information about IMMUCARE-BASE.
- Patient receiving immunotherapy as a part of a clinical trial can be eligible to IMMUCARE-BASE according to the indications given by the promoter of this trial.
Key exclusion criteria (8 listed)
- Patient who had received immunotherapy within 6 months before entering in IMMUCARE-BASE
- Minor patient
- Pregnant women
- Patient under juridical protection
- Patient refusal to participate.
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 |
|---|---|---|
| Estimation of the incidence of the irAEAssessment of the incidence of the irAE in patients treated with immunotherapy at the Hospices Civils de Lyon (irAE of all grades and from all organs) and creation of a biological collection of blood, plasma, serum and PBMCs from patients before treatment, under treatment and at the onset of irAEs. | Other | Patients treated with immunotherapy |
Primary outcome
Estimation of the incidence of immunotherapy-related toxicities (all grades, of all organs, in real life) in patients treated for the first time with anticancer immunotherapy and enrolled in the "IMMUCARE-BASE" clinical database
Time frame: 10 years
Patients can be treated with immunotherapy alone, or in association with other immunotherapies, or association with chemotherapies, targeted therapies or radiotherapy. It will include all types of cancers that can be treated with immunotherapy, also including patients that are in clinical trials.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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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.
Jonathan LOPEZ, MD study director
Hospices Civils de Lyon
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 Cancer, run by Hospices Civils de Lyon 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Jul 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan LOPEZ, MD (+33 4 78 86 16 07 ext. +33, jonathan.lopez@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the incidence of immunotherapy-related toxicities (all grades, of all organs, in real life) in patients treated for the first time with anticancer immunotherapy and enrolled in the "IMMUCARE-BASE" clinical database (time frame: 10 years). 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 27 Jul 2021.