Back to resultsRheumatologic Adverse Events and Cancer Immunotherapy
Primary Purpose
Oncology, Autoimmunity, Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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About this trial
This is an interventional screening trial for Oncology
Eligibility Criteria
Inclusion Criteria:
- Patient with cancer needed to be treated by immunotherapy
Exclusion Criteria:
- Patient already treated by immunotherapy
Sites / Locations
- C.H.U de PoitiersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with cancer immunotherapy treatment
Arm Description
All patients starting immunotherapy treatment will complete a questionnaire to identify rheumatological side effects, each time they come for treatment.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04791150
First Posted
March 5, 2021
Last Updated
May 7, 2021
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04791150
Brief Title
Rheumatologic Adverse Events and Cancer Immunotherapy
Official Title
Rheumatologic Adverse Events and Immunotherapy in Oncology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
July 7, 2022 (Anticipated)
Study Completion Date
November 7, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Autoimmunity, Arthritis, Adverse Drug Event
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with cancer immunotherapy treatment
Arm Type
Experimental
Arm Description
All patients starting immunotherapy treatment will complete a questionnaire to identify rheumatological side effects, each time they come for treatment.
Intervention Type
Other
Intervention Name(s)
Fill in a form
Intervention Description
Patient will have to fill in a form at each perfusion of immunotherapy to tell if they presents rheumatologic clinical signs
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
ONE YEAR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with cancer needed to be treated by immunotherapy
Exclusion Criteria:
Patient already treated by immunotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francoise Debiais, MD PHD
Phone
00335 49 44 44 65
Email
francoise.debiais@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Bel
Email
alice.bel@chu-poitiers.fr
Facility Information:
Facility Name
C.H.U de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debiais Françoise, MD
Phone
0033549444465
Email
françoise.debiais@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Bel Alice
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
NO IPD
Learn more about this trial
Rheumatologic Adverse Events and Cancer Immunotherapy
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