Rheumatologic Adverse Events and Cancer Immunotherapy

NCT ID: NCT04791150

Last Updated: 2021-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2022-11-07

Brief Summary

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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

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Conditions

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Oncology Autoimmunity Arthritis Adverse Drug Event

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fill in a form

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with cancer needed to be treated by immunotherapy

Exclusion Criteria

* Patient already treated by immunotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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C.H.U de Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Francoise Debiais, MD PHD

Role: CONTACT

00335 49 44 44 65

Alice Bel

Role: CONTACT

Facility Contacts

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Debiais Françoise, MD

Role: primary

0033549444465

Bel Alice

Role: backup

Other Identifiers

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ONCOIMMUNO

Identifier Type: -

Identifier Source: org_study_id

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