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Table 1 Study visits – SPIRIT [20]

From: The EPICURE study: a pilot prospective cohort study of heterogeneous and massive data integration in metastatic breast cancer patients

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
  1. a) After written informed consent signature
  2. b) Once a year
  3. c) Blinded assessment only
  4. d) At first evaluation only
  5. e) Only if bone metastasis at screening assessment
  6. f) Food inquiry completed during 3 days: one week day, one weekend day and the day before microbiota sample
  7. g) In case of diarrhea > grade 2 due to treatment
  8. h) First evaluation visit:
  9. Group1 without chemotherapy treatment to be done after 2 cycles
  10. Group1, group2 and group 3 receiving chemotherapy treatment: the first evaluation visits are done 3 months and 6 months after treatment start (= end of chemotherapy)