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

April 24, 2025 updated by: Hospital do Coracao

LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS (CTC) AND CIRCULATING TUMOR DNA (CTDNA) AS A PRECISION MEDICINE TOOL 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04004-030
        • Hcor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

brazilian population

Description

Inclusion Criteria:

Inclusion criteria:

• Age ≥ 18 years;

For locally advanced rectal cancer:

  • Patients with histological confirmation of adenocarcinoma of the distal rectum who are candidates for sphincter preservation and undergoing TNT, a long-course CRT regimen, followed by CT (5-FU + consolidation oxaliplatin);
  • Tumors with a location that requires rectal amputation, except for very early tumors (cT1N0);
  • Absence of distant metastases (M0).

For locally advanced or metastatic stomach cancer:

  • Patients with histological confirmation of adenocarcinoma of the stomach or esophagogastric junction (EGJ) (cT2-4, cN0-3, M0-1) who have not undergone any previous treatment for the disease, surgical or systemic;

  • Patients who will undergo the following treatments:

    1. (T2 to T4, N+ and M0): 4 cycles of FLOT, surgery, + 4 cycles of FLOT (5-Fluorouracil, Oxaliplatin and Docetaxel);
    2. Initial cases: T2 to T4 N0: Surgery followed by adjuvant chemotherapy: CAPOX (capecitabine + oxaliplatin) or FOLFOX (5-Fluorouracil + capecitabine) - 8 cycles;
    3. Initially unresectable T4N3: If PDL1+ and CPS > 5: CT (FOLFOX or XELOX) + nivolumab. If HER-2 + XELOX or FOLOFX + transtuzumab - after 8 cycles evaluate resectability;
    4. Metastatic disease: if HER2 negative - XELOX or FOLFOX with Nivolumab or pembrolizumab. If HER2 positive XELOX or FOLFOX with trastuzumab + pembrolizumab.

For localized or metastatic pancreatic cancer:

  • Patients with histologically confirmed pancreatic adenocarcinoma (cT1-4, N0-2, M0-1) who have not undergone any prior surgical or systemic treatment for the disease.

  • Patients who will undergo the following treatments:

    1. T1 to T3, N0 to N2 - resectable: Surgery followed by 12 cycles of FOLFIRINOX (oxaliplatin, 5-fluorouracil and irinotecan)
    2. Borderline resectable: Neoadjuvant chemotherapy with FOLFIRINOX for 8 cycles and surgery
    3. Unresectable disease - locally advanced: FOLFIRINOX for 12 cycles or Gemcitabine + nanoparticle paclitaxel for 8 cycles

Exclusion Criteria:

  • Mid-rectum tumors or tumors with microsatellite instability.
  • Stomach tumors or early EGJ (cT1N0)
  • Patients who have undergone prior treatment or any surgical intervention in the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: from baseline (day 1) until the date of first documented progression , assessed up to 24months
from the diagnosis of advanced disease to disease progression
from baseline (day 1) until the date of first documented progression , assessed up to 24months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: from the day one until the date of death from any cause, assessed up to 30 months
from the diagnosis of advanced or metastatic disease to death
from the day one until the date of death from any cause, assessed up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Coracao

Collaborators

Fundação Amaral Carvalho, Brazil

Investigators

  • Principal Investigator: Ludmilla T.D. Chinen, PhD, Hospital do Coracao
  • Principal Investigator: LUDMILLA T.D. CHINEN, PhD, Hcor Biobank Coordinator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLENTI
  • 84562324.0.1001.0060 (Registry Identifier: CONEP)
  • CONEP (Registry Identifier: Conselho Nacional de Saúde)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

we can share protocols and redecap data

IPD Sharing Time Frame

start date: jan-2025 end date: dec 2026

IPD Sharing Access Criteria

researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Study Protocol
    Information identifier: blenti
    Information comments: blenti

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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