Rheumatologic Adverse Events and Cancer Immunotherapy

Not Applicable

• Conditions: Adverse Drug Event; Oncology; Autoimmunity; Arthritis
• Interventions: Other: Fill in a form

• Registration Number: NCT04791150
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-10
• Status Verified: 2021-05
• Study Start: 2021-05-07
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-10
• Primary Completion: 2022-07-07
• Study Completion: 2022-11-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patient with cancer needed to be treated by immunotherapy

Exclusion Criteria

• Patient already treated by immunotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with cancer immunotherapy treatment	Fill in a form	All patients starting immunotherapy treatment will complete a questionnaire to identify rheumatological side effects, each time they come for treatment.

Primary Outcome Measures

Name	Time	Method
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	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)

Trial Locations

Locations (1)

C.H.U de Poitiers; 🇫🇷 Poitiers, France