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Rheumatologic Adverse Events and Cancer Immunotherapy

Rheumatologic Adverse Events and Immunotherapy in Oncology

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04791150
Enrollment
400
Registered
2021-03-10
Start date
2021-05-07
Completion date
2022-11-07
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Event, Arthritis, Autoimmunity, Oncology

Brief 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. 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.

Interventions

OTHERFill in a form

Patient will have to fill in a form at each perfusion of immunotherapy to tell if they presents rheumatologic clinical signs

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient with cancer needed to be treated by immunotherapy

Exclusion criteria

* Patient already treated by immunotherapy

Design outcomes

Primary

MeasureTime frameDescription
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 oncologistONE YEARnumber 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)

Countries

France

Contacts

Primary ContactFrancoise Debiais, MD PHD
francoise.debiais@chu-poitiers.fr00335 49 44 44 65
Backup ContactAlice Bel
alice.bel@chu-poitiers.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026