OncologyNCT04791150
Rheumatologic Adverse Events and Cancer Immunotherapy
A study testing Fill in a form in people with Oncology and Autoimmunity, run by Poitiers University Hospital at 1 site in France.
Trial summary
In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Autoimmunity, Arthritis
- What is being tested?
- Fill in a form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2021to 7 Nov 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patient with cancer needed to be treated by immunotherapy
Who cannot join
- Patient already treated by immunotherapy
Trial locations and contacts
1 site in 1 country.
Alice Bel contact
France1 site, 1 recruiting
- Recruiting
C.H.U de Poitiers
Poitiers, 86000
Debiais Françoise, MD, 0033549444465, françoise.debiais@chu-poitiers.fr
Bel Alice
About this study
Official title: Rheumatologic Adverse Events and Immunotherapy in Oncology
In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. If the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs.
The number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist.
The aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.
- Conditions
- Oncology, Autoimmunity, Arthritis, Adverse Drug Event
- Being tested
- Fill in a form
- Medical subject headings
- Neoplasms, Autoimmune Diseases, Arthritis, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fill in a formOther
Patient will have to fill in a form at each perfusion of immunotherapy to tell if they presents rheumatologic clinical signs
| Study group | Role | What they receive |
|---|---|---|
| Patient with cancer immunotherapy treatment | Experimental | All patients starting immunotherapy treatment will complete a questionnaire to identify rheumatological side effects, each time they come for treatment. Receives: Other: Fill in a form |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether a self-questionnaire completed by a patient treated with immunotherapy can identify more patients with rheumatological side effects related to this treatment, compared to the complaint reported by the patient to the oncologist
number of patients referred to a rheumatology consultation thanks to the answers to the questionnaire compared to the number of patients referred to a consultation (from questionnaire and oncologist)
Measured: ONE YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start7 May 2021
- Primary completion7 Jul 2022 (estimated)
- Study completion7 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791150
- Sponsor's protocol ID
- ONCOIMMUNO
- Status last verified
- May 2021
- First submitted
- 5 Mar 2021
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NO IPD
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatologic Adverse Events and Immunotherapy in Oncology
- ClinicalTrials.gov ID
- NCT04791150
- Acronym / sponsor ID
- ONCOIMMUNO
- Conditions
- Oncology, Autoimmunity, Arthritis, Adverse Drug Event
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 7 Jul 2022 (estimated)
- Study completion
- 7 Nov 2022 (estimated)
- First posted
- 10 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.
In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. If the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs.
The number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist.
The aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with cancer immunotherapy treatment | Experimental | Other: Fill in a formAll patients starting immunotherapy treatment will complete a questionnaire to identify rheumatological side effects, each time they come for treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with cancer needed to be treated by immunotherapy
Key exclusion criteria (1 listed)
- Patient already treated by 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 |
|---|---|---|
| Fill in a formPatient will have to fill in a form at each perfusion of immunotherapy to tell if they presents rheumatologic clinical signs | Other | Patient with cancer immunotherapy treatment |
Primary outcome
to determine whether a self-questionnaire completed by a patient treated with immunotherapy can identify more patients with rheumatological side effects related to this treatment, compared to the complaint reported by the patient to the oncologist
Time frame: ONE YEAR
number of patients referred to a rheumatology consultation thanks to the answers to the questionnaire compared to the number of patients referred to a consultation (from questionnaire and oncologist)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No. NO IPD
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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.
Alice Bel contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fill in a form in people with Oncology and Autoimmunity, run by Poitiers University Hospital at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 10 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francoise Debiais, MD PHD (00335 49 44 44 65, francoise.debiais@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine whether a self-questionnaire completed by a patient treated with immunotherapy can identify more patients with rheumatological side effects related to this treatment, compared to the complaint reported by the patient to the oncologist (time frame: ONE 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 10 May 2021.