Rheumatologic Adverse Events and Cancer Immunotherapy

NCT04791150 | Unknown

• 1 other identifier: ONCOIMMUNO
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Autoimmunity; Arthritis; Adverse Drug Event

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient with cancer immunotherapy treatment

EXPERIMENTAL

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

Interventions

Fill in a form OTHER

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

Patient with cancer immunotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with cancer needed to be treated by immunotherapy

You may not qualify if:

• Patient already treated by immunotherapy

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

C.H.U de Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Autoimmune Diseases; Arthritis; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Chemically-Induced Disorders

Central Study Contacts

Francoise Debiais, MD PHD

CONTACT

00335 49 44 44 65; francoise.debiais@chu-poitiers.fr

Alice Bel

CONTACT

alice.bel@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: May 7, 2021
• Primary Completion: July 7, 2022
• Study Completion: November 7, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)