Box 1.
Informed consent options and main objectives of PLCRC.
| IC options within the PLCRC cohort |
|---|
| Mandatory |
| 1. Informed consent for longitudinal observational clinical data collection |
| Optional |
|
2. Informed consent for providing PRO (hard-copy or electronic) (a) In case of electronic patient-reported outcomes (ePRO), patients can choose to receive a summarized evaluation of their HRQoL (incl. optional comparisons with average scores of sex- and age-matched CRC patients and/or the non-cancer population) and share these data with their healthcare professional |
| 3. Informed consent to approach the patient for future studies and to use their data in comparative research according to the Trials within Cohorts (TwiCs) design |
| 4. Informed consent for biobanking of (tumor) tissue |
| 5. Informed consent for providing additional blood samples during routine blood withdrawal for observational studies or biobanking |
| 6. Informed consent to receive information in case of new relevant DNA abnormalities |
| Objectives of the PLCRC cohort |
| To prospectively collect detailed data on medical history, serious comorbidities, basic physical examination, imaging results, pathology results, tumor characteristics, treatments, treatment outcomes, hospital stays, interventions and adverse events |
| To collect blood and (tumor) tissue material, obtained during routine practice, for ongoing and future research |
| To provide more accurate treatment data, and clinical and patient-reported outcomes of CRC in daily clinical practice |
|
To create a continuous basis for a large variety of research purposes including, but not limited to: Etiologic, diagnostic, and prognostic research Basic and (epi)genetic research Interventional studies according to TwiCs designs Healthcare policy and cost-effectiveness studies |