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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adverse Drug Event
• Arthritis
• Autoimmunity
• Drug-Related Side Effects and Adverse Reactions
• Neoplasms
• Oncology

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