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

Centre Francois Baclesse

Status: Completed

Conditions: Patients With Cancer Who Start Immunotherapy; All Neoplasms

Treatments: Other: Cognitive test passations

Study type: Interventional

Funder types: Other

Identifiers

NCT03599830

2018-A01041-54

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Cognitive test passations

Other group

Description:

3 neuropsychological passations over a period of 6 months.

Treatment:

Other: Cognitive test passations