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

NCT06940778 | Active Not Recruiting DMC

• 3 other identifiers: BLENTI84562324.0.1001.0060CONEP
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer of Rectum; Cancer of Pancreas; Cancer of Stomach

Keywords

locally advanced rectal cancer; locally advanced and metastatic pancreas cancer; locally advanced and metastatic gastric cancer; circulating tumor cells; circulating tumor DNA; liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival

  from the day one until the date of death from any cause, assessed up to 30 months

Interventions

No Interventions OTHER

no interventions

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

brazilian population

You may qualify if:

• 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:
• (T2 to T4, N+ and M0): 4 cycles of FLOT, surgery, + 4 cycles of FLOT (5-Fluorouracil, Oxaliplatin and Docetaxel);
• Initial cases: T2 to T4 N0: Surgery followed by adjuvant chemotherapy: CAPOX (capecitabine + oxaliplatin) or FOLFOX (5-Fluorouracil + capecitabine) - 8 cycles;
• 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;
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead
• Fundação Amaral Carvalho, Brazil: collaborator

Study Sites (1)

Hcor

São Paulo, São Paulo, 04004-030, Brazil

Location

Related Publications (3)

• 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.

  PMID: 30846515 BACKGROUND

• 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.

  PMID: 34207124 BACKGROUND

• 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.

  PMID: 35107490 BACKGROUND

Related Links

• we work with liquid biopsy since 2011, with many papers published in solid and mesenchymal tumors.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood will be collected and circulating tumor cells and circulating tumor DNA will be isolated and analysed

MeSH Terms

Conditions

Rectal Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludmilla T.D. Chinen, PhD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• LUDMILLA T.D. CHINEN, PhD

  Hcor Biobank Coordinator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: start date: jan-2025 end date: dec 2026
• Access Criteria: researchers

Locations

BR (1)