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

Study acronym: BLENTI
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record status
This record was last updated April 27, 2025 (before its estimated June 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study description shortened, about 264 words
    • Study title shortened, about 4 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06940778
Lead Sponsor Hospital do Coracao
Collaborators: Fundação Amaral Carvalho, Brazil
Conditions
(from sponsor)		 Cancer of Rectum, Cancer of Pancreas, Cancer of Stomach
Related terms Neoplastic Cells, Circulating, Pancreatic Neoplasms, Rectal Neoplasms, Stomach Neoplasms
Enrollment 273 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov