Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer

TRACC Part B This is a multi-centre, prospective, translational research study involving the collection and analysis of tumour tissue, serial blood samples and clinical data in patients with newly diagnosed stage I, II and III CRC. TRACC Part C is a : (multi-centre, prospective, randomised study, of ctDNA guided adjuvant chemotherapy versus standard of care adjuvant chemotherapy study after curative surgery in patients with high risk stage II or stage III CRC. )It aims to demonstrate that a de-escalation strategy of ctDNA guided adjuvant chemotherapy is non- inferior to standard of care treatment as measured by 3 year disease free survival (DFS) in patients with high risk stage II or stage III colorectal cancer CRC with no evidence of minimal residual disease (MRD) (ctDNA negative)

NCT Number	NCT04050345
Lead Sponsor	Royal Marsden NHS Foundation Trust
Conditions	Colorectal Cancer
Enrollment	1,000 participants
Start Date	2016-12-05
Primary Completion	2029-07-31 (estimated)
Study Completion	2031-07-31 (estimated)
Updated on ClinicalTrials.gov	2024-06-14