Rheumatologic Adverse Events and Cancer Immunotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis; Oncology; Adverse Drug Event; Autoimmunity
• Intervention / Treatment: Other: Fill in a form

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francoise Debiais, MD PHD; Phone Number: 00335 49 44 44 65; Email: francoise.debiais@chu-poitiers.fr
• Study Contact Backup: Name: Alice Bel; Email: alice.bel@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • C.H.U de Poitiers
    • Contact: Debiais Françoise, MD; Phone Number: 0033549444465; Email: françoise.debiais@chu-poitiers.fr
    • Contact: Bel Alice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with cancer needed to be treated by immunotherapy

Exclusion Criteria:

• Patient already treated by immunotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with cancer immunotherapy treatment; All patients starting immunotherapy treatment will complete a questionnaire to identify rheumatological side effects, each time they come for treatment.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Anticipated): July 7, 2022
• Study Completion (Anticipated): November 7, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Neoplasms; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: ONCOIMMUNO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: NO IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No