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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric and colon cancer patients without macroscopic peritoneal diffusion | Examination of peritoneal washing with both traditional cytology and OSNA assay |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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University
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| Name | Affiliation | Role |
|---|---|---|
| Gennaro Galizia, MD | University of Campania Luigi Vanvitelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campania "Luigi Vanvitelli" | Naples | Campania | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35864130 | Background | 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. | |
| 29112563 |
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all data will be shared after publication
one month after publication
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| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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. |
| 40887569 | 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. |
| 40977665 | 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. |
| D004066 |
| Digestive System Diseases |
| D010532 | Peritoneal Diseases |