Molecular Citology to Detect Free Cancer Cells in Peritoneal Fluid

In gastrointestinal malignancies peritoneal diffusion represent a severe adverse event. Current methodoly including cytology of peritoneal fluid appears insufficient. It's crucial to individuate new technology.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Campania "Luigi Vanvitelli"

Naples, Campania, 80131, Italy

About this study

The one-step nucleic acid amplification (OSNA) assay is an emergent tool to detect cancer cells in the lymph nodes of several human malignancies including gastrointestinal tumors. The technique identifies and amplifies CK19 mRNA expressed by epithelial cells and has proven easy, rapid, and effective in detecting metastatic cells in lymph nodes. We hypothesized that this methodology could be used to detect free tumor cells in the peritoneal fluid of patients with gastric and colon cancers.

Before the start of the study, five patients suffering of peritoneal carcinomatosis with ascitis (2 from gastric and 3 from colon cancer) served as control. In all five control patients with overt peritoneal metastases, peritoneal washing was positive both cytology and OSNA examination (ranging from 200 to 2,000,000 cCP/µL), showing that OSNA assay is able to identify free cancer cells in a fluid (sensitivity 100%).

A series of 108 consecutive oncological patients (44 gastric and 64 colon cancers) undergoing surgery entered the study. In each patient peritoneal washing was submitted to both traditional cytology and OSNA examination.

The OSNA assay was positive in sixteen patients (14.8%) ranging from 200 to 1,4000,000 cCP/µL. Six gastric cancer patients (13.6%) and ten colon cancer patients (15.6%), with no evidence of peritoneal diffusion, showed free cancer cells in the peritoneal lavage fluid. On the contrary, routine cytologic examination was positive in only four patients (3.7%; two gastric and two colon cancers) who were simultaneously positive at OSNA assay (twelve false negative cases, cytology sensitivity 57.1% assuming OSNA results as true positive cases).

This study suggests that OSNA assay offers a significant advantage over conventional cytology and shoul be widely used to identify gastrointestinal cancer patients at high risk of peritoneal diffusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Gastric and colon cancer patients with no evidence of peritoneal carcinomatosis undergoing surgery

Exclusion criteria

Oncological patients with overt peritoneal diffusion

Treatment and study plan

Primary outcomes

Sensitivity of both traditional cytology and OSNA assay to detect free cancer cells in the peritoneal fluid of patients with gastric or colon cancers.

Time frame: The OSNA technique requires almost 30 minutes. Follow-up time of patients has a mean of 15 months.

The OSNA assay was defined positive if at least a numer higher 160 cCP/µL was detected.

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Application of the One-step Nucleic Acid Amplification (OSNA) Assay to Detect Free Cancer Cells in the Peritoneal Washing of Gastric and Colon Cancer Patients

Acronym: OSNA

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Mar 17, 2026
Registry last updated: Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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