Cognitive assessment in patients treated by immunotherapy: the prospective Cog-Immuno trial

BMC Cancer

Table 1 Overview of the Cog-Immuno study assessments

Assessment	T0^c	T3 3 months	T6 6 months
Signed informed consent	✓
Cognitive assessment^a
-MoCA²	✓	✓	✓
If normal MoCA score^b:
-Hopkins verbal learning test	✓	✓	✓
-Digit span (WAIS-IV)	✓	✓	✓
-Trail Making test	✓	✓	✓
-Stroop	✓	✓	✓
-Symbol search (WAIS-IV)	✓	✓	✓
-Verbal fluencies	✓	✓	✓
-Cancellation (WAIS-IV)	✓	✓	✓
-Line bissection	✓
Self-report questionnaires
FACT-Cog, FACIT-F, HADS	✓	✓	✓
ECG^d	✓
Biological sample
Biological tests^e	✓	✓	✓
Research specific blood samples^f	✓	✓	✓

^a Cognitive assessments by a neuropsychologist
^b At baseline, the MoCA score should be above threshold value based on age and education level normative data (Table 2) to realize the complete cognitive battery. In the case of MoCA score below threshold value, only MoCA and self-report questionnaires will be proposed to the patient for baseline, 3 and 6 months assessments
^c Before the start of the treatment or within 7 days after the start of immunotherapy
^d Standard ECG required for all participating centres. A 5-minute ECG will be performed for centres with a specific device. A centralized review of the ECGs is planned
^e CBC-platelets, sodium, potassium, ALKP, ASAT, ALAT, GGT, total bilirubin, creatinin, albumin, CRP and TSH
^f For patients with specific informed written consent for constitution of a biobank of PBMC, serum and plasma from blood samples: 2 CPTTM (2X4 mm) and 1 BD vacutainer serum tube (5 ml)

ISSN: 1471-2407