LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS AND CIRCULATING TUMOR DNA AS PRECISION MEDICINE IN GASTROINTESTINAL TUMORS

This is a prospective, observational, multicenter cohort study. Our main objective is to to evaluate the use of CTCs and ctDNA with prognostic factors in locally advanced rectal tumors treated with total neoadjuvant therapy (TNT), recently adopted as clinical practice, and to analyze the functionality of CTCs and ctDNA in the follow-up of locally advanced and metastatic pancreatic and gastric tumors. Secondary objectives: * To verify the influence of CTC and ctDNA kinetics on the response to treatment of the three tumors; * To correlate RAD23B/TYMS findings and CTC kinetics with DFS in locally advanced rectal tumors; * To correlate HER-2 and PDL-1 expression in CTCs in gastric cancer with progression-free and overall survival; * To verify the correlation between EGFR methylation in ctDNA of metastatic gastric tumors and PFS and OS; * Correlate KRAS mutations in ctDNA in locally advanced pancreatic and rectal cancer with progression-free and overall survival; * Compare the mutational profile of the primary tumor with that of the main components of the liquid biopsy (CTCs and ctDNA), in the three disease scenarios.

NCT Number	NCT06940778
Lead Sponsor	Hospital do Coracao Collaborators: Fundação Amaral Carvalho, Brazil
Conditions	Cancer of Rectum, Cancer of Pancreas, Cancer of Stomach
Enrollment	273 participants
Start Date	2025-01-10
Primary Completion	2026-06-10 (estimated)
Study Completion	2026-12-10 (estimated)
Updated on ClinicalTrials.gov	2025-04-27