Trials / Active Not Recruiting
Active Not RecruitingNCT06940778
LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS AND CIRCULATING TUMOR DNA AS PRECISION MEDICINE IN GASTROINTESTINAL TUMORS
LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS (CTC) AND CIRCULATING TUMOR DNA (CTDNA) AS A PRECISION MEDICINE TOOL IN GASTROINTESTINAL TUMORS
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 273 (estimated)
- Sponsor
- Hospital do Coracao · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
To evaluate CTCs we will isolate cells from blood of patients by ISET method (Rarecells, France). The DNA from CTCs will be evaluated by digital PCR (Qiagen). Also, the ctDNA. Patients will be evaluated three times ( before the beginning of therapy, 6 and 12 months later. The study will be only observational. Patients will be followed by clinical and images exams.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Interventions | no interventions |
Timeline
- Start date
- 2025-01-10
- Primary completion
- 2026-06-10
- Completion
- 2026-12-10
- First posted
- 2025-04-23
- Last updated
- 2025-04-27
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT06940778. Inclusion in this directory is not an endorsement.