Cancer types
  • Digestive tract
Title of study
Prospective data collection initiative on colorectal cancer: a prospective observational cohort study
Version Number
Approval Date 
11, 29 March 2016
Short Title
Plcrc
Study site
Principle Investigator
Dr M. Koopman, Dept of Medical Oncology UMC Utrecht
Investigator Maastro
Dr M. Berbée
Sponsor
Trial registry
Objectives 

• To start a prospective observational cohort study of CRC patients from their primary diagnosis until death
• After obtaining informed consent, to prospectively collect data on medical history, comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and (S)AEs
• After obtaining separate informed consent for collecting data on health related quality of life and work ability, to collect data on patient reported outcome measures
• After obtaining separate informed consent, to collect blood and tumor tissue material, obtained during routine practice, for observational studies or storage in the biobank. The cohort will serve as an infrastructure geared towards efficient, safe and comprehensive clinical evaluation of new interventions for patients with CRC according to the cohort multiple randomized clinical trial (cmRCT) design

Primary Endpoint 

• Clinical parameters: medical history, co-morbidity, medication use, basic physical examination, laboratory results, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and adverse events
• Clinical endpoints: treatment effect, adenoma-free survival, disease-free survival, progression-free survival, overall survival and grade 3-4 (serious ) adverse events
• Patient reputed outcomes: health related quality of life, word participation and work abilityBiobanking of blood and tumor tissue

Secondary Endpoints