Molecular Citology to Detect Free Cancer Cells in Peritoneal Fluid

NCT07478107 | Completed DMC

• 1 other identifier: Campania University
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peritoneal Carcinomatosis

Keywords

One-step nucleic acid amplification; OSNA assay; Gastrointestinal Malignancies

Outcome Measures

Primary Outcomes (1)

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

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

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

Study Arms (1)

Gastric and colon cancer patients without macroscopic peritoneal diffusion

Examination of peritoneal washing with both traditional cytology and OSNA assay

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University

You may qualify if:

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

You may not qualify if:

• Oncological patients with overt peritoneal diffusion

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania "Luigi Vanvitelli"

Naples, Campania, 80131, Italy

Location

Related Publications (4)

• Geca K, Skorzewska M, Rawicz-Pruszynski K, Mlak R, Sedlak K, Pelc Z, Malecka-Massalska T, Polkowski WP. Prognostic value of molecular cytology by one-step nucleic acid amplification (OSNA) assay of peritoneal washings in advanced gastric cancer patients. Sci Rep. 2022 Jul 21;12(1):12477. doi: 10.1038/s41598-022-16761-8.

  PMID: 35864130 BACKGROUND

• Galizia G, Lieto E, Auricchio A, Cardella F, Mabilia A, Podzemny V, Castellano P, Orditura M, Napolitano V. Naples Prognostic Score, Based on Nutritional and Inflammatory Status, is an Independent Predictor of Long-term Outcome in Patients Undergoing Surgery for Colorectal Cancer. Dis Colon Rectum. 2017 Dec;60(12):1273-1284. doi: 10.1097/DCR.0000000000000961.

  PMID: 29112563 BACKGROUND

• Kong D, Li Y, Yin S, Tan Y, Qu B, Huang L, Xi JJ, Wu A. Peritoneal Lavage Cytology Predicts Peritoneal Metastasis and is Associated with Poor Prognosis in Patients with Stage II-III Colorectal Cancer. Ann Surg Oncol. 2025 Dec;32(13):9712-9722. doi: 10.1245/s10434-025-18176-x. Epub 2025 Sep 1.

  PMID: 40887569 BACKGROUND

• Sugiyama Y, Tanabe K, Yanagawa S, Tazawa H, Toyota K, Kano M, Misumi T, Shishida M, Okano K, Hotta R, Ota H, Imaoka Y, Fukuda T, Takahashi S, Ohdan H. Prognostic factors and efficacy of postoperative chemotherapy in patients with gastric cancer with positive peritoneal cytology after gastrectomy. World J Gastrointest Oncol. 2025 Sep 15;17(9):110245. doi: 10.4251/wjgo.v17.i9.110245.

  PMID: 40977665 BACKGROUND

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gennaro Galizia, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 23 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: July 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: February 28, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: one month after publication
• Access Criteria: email gennaro.galizia@unicampania.it

Locations

IT (1)