Study of the Cognition of Patients Treated With Immunotherapy (COG-IMMUNO)

Study of the Cognition of Patients Treated With

The investigator's longitudinal pilot study aims to evaluate for the first time the impact of immunotherapy on cognition in oncology.

Due to the recent nature of immunotherapy, its side effects and impact on quality of life are still poorly understood and, to date, there is no published study evaluating the impact of immunotherapy on cognition in patients treated for cancer.

The study consists of the passation of 3 neuropsychological assessments over a period of 6 months in cancer patients who start immunotherapy

Study Overview

• Status: Completed
• Conditions: Patients With Cancer Who Start Immunotherapy; All Neoplasms
• Intervention / Treatment: Other: Cognitive test passations

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florence JOLY, Prof; Phone Number: 0231455050; Email: f.joly@baclesse.unicancer.fr

Study Locations

• France
  • Amiens, France
    • CHU Amiens
  • Caen, France
    • Centre François Baclesse
  • Caen, France, 14000
    • CHU Caen
  • Lille, France
    • CHRU Lille

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient over the age of 18,
• Patient with cancer and having to initiate treatment with immunotherapy alone
• Treatment with immunotherapy will include either an anti-PD1 / L1 or Anti CTLA4 monotherapy or combination,
• Patients may have received other antitumor treatments other than immunotherapy but these should be stopped at the time of initiation of immunotherapy
• Performance Status <2
• Patient at the level of studies 3 "end of primary studies" minimum (Barbizet scale),
• Mastery of the French language.
• Patient affiliated to a social security system
• Patient having attested in writing of his non-opposition to participate in the study

Exclusion Criteria:

• Previous treatment with immunotherapy
• Another anti-tumor treatment underway
• Primary cancer of the central nervous system or cerebral metastasis, symptomatics and not controlled
• Abuse of alcohol or drug use
• Severe visual and / or auditory deficiency,
• Refusal of participation of the patient.
• Patient deprived of liberty or under guardianship
• Patient unable to follow the study for geographical, social or psychopathological reasons

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cognitive test passations; 3 neuropsychological passations over a period of 6 months.	Other: Cognitive test passations; Tests : MoCA2 Hopkins verbal learning test WAIS-IV Trail Making test Stroop Verbal fluences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive function (at least in a cognitive domain)	The proportion of patients who will have a reduction of scores in neuropsychological questionnaires (scores of MoCA2, Hopkins verbal learning test, WAIS-IV, Trail Making test, Stroop Symboles)	between inclusion and 3 months.

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Immunotherapy; Cognition
• Other Study ID Numbers: 2018-A01041-54

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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