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

Study Overview

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.

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.

Cancer of Rectum
Cancer of Pancreas
Cancer of Stomach

OTHER: No Interventions

BLENTI
84562324.0.1001.0060 (REGISTRY Identifier) (REGISTRY: CONEP)
CONEP (REGISTRY Identifier) (REGISTRY: Conselho Nacional de Saúde)

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-24
First Submitted that Met QC Criteria 2025-04-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-27
First Posted (ACTUAL) 2025-04-23	Results First Posted N/A	Last Verified 2025-04

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
disease free survival	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	Measure Description	Time Frame
overall survival	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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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).

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:

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:

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.

Collaborators and Investigators

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

Fundação Amaral Carvalho, Brazil

Investigators

PRINCIPAL_INVESTIGATOR: Ludmilla T.D. Chinen, PhD, Hospital do Coracao

Publications

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

General Publications

Abdallah EA, Braun AC, Flores BCTCP, Senda L, Urvanegia AC, Calsavara V, Fonseca de Jesus VH, Almeida MFA, Begnami MD, Coimbra FJF, da Costa WL Jr, Nunes DN, Dias-Neto E, Chinen LTD. The Potential Clinical Implications of Circulating Tumor Cells and Circulating Tumor Microemboli in Gastric Cancer. Oncologist. 2019 Sep;24(9):e854-e863. doi: 10.1634/theoncologist.2018-0741. Epub 2019 Mar 7.
Silva VSE, Abdallah EA, Flores BCT, Braun AC, Costa DJF, Ruano APC, Gasparini VA, Silva MLG, Mendes GG, Claro LCL, Calsavara VF, Aguiar Junior S, de Mello CAL, Chinen LTD. Molecular and Dynamic Evaluation of Proteins Related to Resistance to Neoadjuvant Treatment with Chemoradiotherapy in Circulating Tumor Cells of Patients with Locally Advanced Rectal Cancer. Cells. 2021 Jun 18;10(6):1539. doi: 10.3390/cells10061539.
Tarazona JGR, Abdallah EA, Flores BCT, Braun AC, Camillo CMC, Marchi FA, Ruano APC, Chinen LTD. MIR-203A-3P AND MMP-2 PROTEINS ARE HIGHLY EXPRESSED IN CIRCULATING TUMOR CELLS FROM PATIENTS WITH PANCREATIC CARCINOMA. Arq Bras Cir Dig. 2022 Jan 31;34(4):e1628. doi: 10.1590/0102-672020210002e1628. eCollection 2022.

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