Concept 4: Longitudinal collection of data to capture the whole story of a rare, complex tumor with long-term survival, including baseline characteristic and major changes in characterisation

Solution: Different sections of data insertion are available reflecting the journey of each patient


  • Baseline data: Data is collected (does not mean captured in the DB) in the center (NEN referral center or non-NEN referral center if the visit in the NEN referral center did not occur within the appropriate time frame) BEFORE 6 months from first NET or < 2 months from first NEC DIAGNOSIS as defined by:
    • First choice: Date of pathology if available within the appropriate time frame or
    • Second choice: Date of first positive imaging if pathology is not available within the appropriate time frame or
    • Third choice: Date of first imaging work-up at the time of functioning syndrome diagnosis if positive imaging is not available within the appropriate time frame
  • Major change data are defined by changes in WHO, TNM, functioning Sd, SRI categorisation during the course of the tumor as defined by AFTER 6 months from NET or 2 months from NEC diagnosis as defined above.
  • Major changes are classified in 2 subgroups:
    • True changes due to tumor progression or therapeutic pressure
    • Optimisation, which means changes due to review of old exams or new exams not performed at baseline.

The major change section is also used to re-characterise patients for a level 3 study for which the baseline of the study is different from the BASELINE of the DB which is defined by the date of diagnosis.