All Neoplasms Clinical Trial
— COG-IMMUNOOfficial title:
Study of the Cognition of Patients Treated With
| Verified date | February 2024 |
| Source | Centre Francois Baclesse |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | January 31, 2023 |
| Est. primary completion date | January 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Amiens | Amiens | |
| France | Centre François Baclesse | Caen | |
| France | CHU CAEN | Caen | |
| France | Chru Lille | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Francois Baclesse |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |