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NCT04791150 Clinical Trial

Rheumatologic Adverse Events and Cancer Immunotherapy

Arthritis Clinical Trial

Official title:
Rheumatologic Adverse Events and Immunotherapy in Oncology

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04791150
Other study ID # ONCOIMMUNO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 7, 2021
Est. completion date November 7, 2022

Study information
Verified date May 2021
Source Poitiers University Hospital
Contact Francoise Debiais, MD PHD
Phone 00335 49 44 44 65
Email francoise.debiais@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date November 7, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with cancer needed to be treated by immunotherapy Exclusion Criteria: - Patient already treated by immunotherapy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France C.H.U de Poitiers Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) ONE YEAR
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