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Study of the Cognition of Patients Treated With Immunotherapy

Study of the Cognition of Patients Treated With

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03599830
Acronym
COG-IMMUNO
Enrollment
90
Registered
2018-07-26
Start date
2018-07-10
Completion date
2023-01-31
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All Neoplasms, Patients With Cancer Who Start Immunotherapy

Keywords

Immunotherapy, Cognition, Cancer

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

Interventions

OTHERCognitive test passations

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

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026