Work package 2: Multi-centre observational study

Objectives:

 

1.To establish a prospective cohort of patients undergoing radiotherapy for breast, prostate or lung cancers according to a standardized protocol for the study of determinants of radiotherapy side-effects.

2. To establish a comprehensive database and sample collection as a resource for prospective evaluation and validation of models and biomarkers for early detection of radiotherapy side-effects.

 

Deliverables:

 

2.1) Final version of trial protocol as submitted to ethics and register observational study on a WHO or ICMJE approved clinical trials registry.

2.2) Ethics and regulatory approvals obtained.

2.3) Standardized data forms, ICF, PIS posted on website and centralized database operational: Standardized data forms, example consent form and example patient information sheet posted on REQUITE website and first version centralized database with web-based electronic clinical reporting form for data collection installed and operational.

2.4) Report of patient recruitment on REQUITE website: Person months to carry out the patient recruitment work are within 'other direct costs' under a 'per patient cost' model. To view the report click here.

2.5) Report on the status of the posting of results to the trial registry: Person months to carry out the patient follow-up work are within 'other direct costs' under a 'per patient cost' model.

2.6) Report on all recruited patients placed on REQUITE website.