Clinical trial · Observational
Molecular Citology to Detect Free Cancer Cells in Peritoneal Fluid
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
NCT07478107CI-TRIAL-00106124OSNAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Gastric and colon cancer patients without macroscopic peritoneal diffusion
- description
- Examination of peritoneal washing with both traditional cytology and OSNA assay
Primary outcomes (1)
- measure
- Sensitivity of both traditional cytology and OSNA assay to detect free cancer cells in the peritoneal fluid of patients with gastric or colon cancers.
- timeFrame
- The OSNA technique requires almost 30 minutes. Follow-up time of patients has a mean of 15 months.
- description
- The OSNA assay was defined positive if at least a numer higher 160 cCP/µL was detected.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Gastric and colon cancer patients with no evidence of peritoneal carcinomatosis undergoing surgery Exclusion Criteria: * Oncological patients with overt peritoneal diffusion
References
Publications (4)
- BACKGROUNDGeca 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
- BACKGROUNDGalizia 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
- BACKGROUNDKong 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
- BACKGROUNDSugiyama 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