Multi-omics evaluation of peritoneal fluid in gastroesophageal cancer (OMEGCA): protocol for a prospective multicentre cohort study to detect occult peritoneal metastases in patients undergoing curative-intent treatment

PLoS One. 2025 Apr 16;20(4):e0318615. doi: 10.1371/journal.pone.0318615. eCollection 2025.

Abstract

Introduction: Early detection of peritoneal disease, especially micro-metastases, in patients with gastroesophageal adenocarcinoma is critical as it alters therapeutic intent, providing a vital opportunity to personalise treatment. However, our ability to accurately stage the peritoneum is inadequate. Tumour-derived DNA in peritoneal lavage fluid (ptDNA) has been suggested to be more sensitive than current methods to stage the peritoneum. Accordingly, this study will determine whether ptDNA is a biomarker of peritoneal micro-metastasis and evaluate its prognostic value in patients with gastroesophageal adenocarcinoma undergoing curative-intent treatment.

Methods and analysis: This will be an Australian multi-centre prospective observational cohort study enrolling patients undergoing routine staging laparoscopy and subsequent curative-intent treatment (either upfront surgery or perioperative chemo-/radiotherapy and surgery) for gastric and gastroesophageal junction adenocarcinoma. Tumour biopsies, blood and peritoneal lavage fluid will be collected at the time of staging laparoscopy for all patients. A subset of patients will have blood and peritoneal fluid collected at the time of surgical resection, and blood collected at the first post-operative clinic. These biospecimens will undergo genomic and methylomic analysis to detect tumour DNA. ptDNA status will be correlated to disease free survival, peritoneal-specific event free survival, overall survival, sites of treatment failure, histopathological features, and peritoneal lavage cytology status.

Registration: This study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000451505p).

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adenocarcinoma* / genetics
  • Adenocarcinoma* / pathology
  • Adenocarcinoma* / therapy
  • Ascitic Fluid* / metabolism
  • Australia
  • Biomarkers, Tumor / genetics
  • DNA, Neoplasm / genetics
  • Esophageal Neoplasms* / genetics
  • Esophageal Neoplasms* / pathology
  • Esophageal Neoplasms* / therapy
  • Esophagogastric Junction / pathology
  • Female
  • Humans
  • Male
  • Multiomics
  • Peritoneal Neoplasms* / diagnosis
  • Peritoneal Neoplasms* / genetics
  • Peritoneal Neoplasms* / secondary
  • Prognosis
  • Prospective Studies
  • Stomach Neoplasms* / genetics
  • Stomach Neoplasms* / pathology
  • Stomach Neoplasms* / therapy

Substances

  • Biomarkers, Tumor
  • DNA, Neoplasm

Grants and funding

This work is supported by an Innovation Grant from the Australasian Gastro-Intestinal Trials Group (AGITG)/GI Cancer Institute, as well as a Victorian Cancer Agency Mid-Career Research Fellowship Grant. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.