Study of the Cognition of Patients Treated With

Centre Francois Baclesse4 sites in 1 country90 target enrollmentJuly 10, 2018

ConditionsPatients With Cancer Who Start Immunotherapy All Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients With Cancer Who Start Immunotherapy
Sponsor: Centre Francois Baclesse
Enrollment: 90
Locations: 4
Primary Endpoint: Change in cognitive function (at least in a cognitive domain)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 10, 2018

End Date

January 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Francois Baclesse

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in cognitive function (at least in a cognitive domain)

Time Frame: between inclusion and 3 months.

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)