Study Period | |||||
---|---|---|---|---|---|
Assessments to be performed at the times stipulated in the table and as clinically required in the management of the patient | SCREENING ASSESSMENT | TREATMENT LINE (to be repeated at each progression) | DISEASE PROGRESSION VISIT | ||
Treatment | Early Evaluation | Evaluation visits | |||
Time point | 0 to 4 weeks ± 7 days | After cycle 1 | (h) | ||
Informed consent | X | ||||
Eligibility screen | X | ||||
Medical history + demographics | X | ||||
Patient registration and enrollment | X(a) | ||||
PATIENT REPORTED OUTCOME (PRO) | |||||
Socio-demographic characteristics | X(a) | X(b) | |||
STAI TRAI | X | ||||
STAI ETAT | X | X | |||
QLQ-C30, QLQ-BR23, EDP,, BDI-II, physical activity questionnaire | X(a) | X | X | ||
Food Frequency questionnaire | X(a) | X | |||
Food inquiry | X(a; f) | X(f; g) | X(f) | ||
PTGI | X(b) | ||||
CLINICAL EXAM | |||||
Physical exam, height, Weight, WHO performance status | X | X | X | ||
AE/SAE assessment + Concomitant medications | X | X | X | ||
Vital signs: temperature, respiratory rate, blood pressure, pulse, ECG | X | X | X | ||
BIOLOGY: STANDARD LABORATORY TESTS | |||||
Hematology, Coagulation parameters, Clinical chemistry, Thyroid function tests (1) | X | X | X | ||
Disease-specific tumor markers (2) | X | X | X | ||
Urine dipstick analysis (3) | X | X | X | ||
βHCG (if applicable) | X | ||||
IMAGING EXAMS | |||||
Chest/Abdomen and Pelvis CT scan | X | X | X | ||
18FDG PET/CT | X | X(c) | X(d) | X | |
Bone Scan | X | X(e) | X | ||
BIOLOGICAL AND BIOPATHOLOGICAL SAMPLING | |||||
Pathology: archived primary tumor sample | X | ||||
Pathology: metastatic biopsy | X(a) | X | |||
Biological blood samples: epigenetics biomarkers, cDNA, miRNA | X(a) | X | X | X | |
Biological blood samples: Circulating Tumor Cell - CTC | X(a) | X | |||
Biological blood samples: Sphingolipids and extracellular vesicles | X(a) | X | X | ||
Biological blood samples: proteomic analysis | X(a) | X | |||
Urine sample: Molecular analysis | X(a) | X | |||
Microbiota sample | X(a) | X(g) | X | ||
TREATMENTS | |||||
Treatment according to patient group | X |