Study of the Cognition of Patients Treated With Immunotherapy

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

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Key information

Conditions

Patients With Cancer Who Start Immunotherapy All Neoplasms Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Amiens, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive test passations

Other

Tests :

MoCA2 Hopkins verbal learning test WAIS-IV Trail Making test Stroop Verbal fluences

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)

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study title

Study of the Cognition of Patients Treated With

Acronym: COG-IMMUNO

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Jul 26, 2018
Registry last updated: Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed