Peritoneal CarcinomatosisOSNANCT07478107
Molecular Citology to Detect Free Cancer Cells in Peritoneal Fluid
An observational study of Peritoneal Carcinomatosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peritoneal Carcinomatosis
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 28 Feb 2026
- How long will I take part?
- 23 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: University
Who may be able to join
- Gastric and colon cancer patients with no evidence of peritoneal carcinomatosis undergoing surgery
Who cannot join
- Oncological patients with overt peritoneal diffusion
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- One-step nucleic acid amplification, OSNA assay, Gastrointestinal Malignancies
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric and colon cancer patients without macroscopic peritoneal diffusion | Examination of peritoneal washing with both traditional cytology and OSNA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The OSNA technique requires almost 30 minutes. Follow-up time of patients has a mean of 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jul 2024
- Primary completion31 Oct 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 23 Months
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Galizia, University of Campania Luigi Vanvitelli
- Investigators
- Gennaro Galizia, MD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478107
- Sponsor's protocol ID
- Campania University
- Acronym
- OSNA
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be shared after publication
Publications
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.
PubMed 35864130Galizia 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.
PubMed 29112563Kong 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.
PubMed 40887569Sugiyama 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.
PubMed 40977665
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07478107
- Acronym / sponsor ID
- OSNA / Campania University
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- One-step nucleic acid amplification, OSNA assay, Gastrointestinal Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 23 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric and colon cancer patients without macroscopic peritoneal diffusion | – | –Examination of peritoneal washing with both traditional cytology and OSNA assay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- University
Key inclusion criteria (1 listed)
- Gastric and colon cancer patients with no evidence of peritoneal carcinomatosis undergoing surgery
Key exclusion criteria (1 listed)
- Oncological patients with overt peritoneal diffusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 35864130Geca 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.
- Background: PubMed 29112563Galizia 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.
- Background: PubMed 40887569Kong 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.
- Background: PubMed 40977665Sugiyama 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.
- Individual participant dataSharing planned: Yes. all data will be shared after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gennaro Galizia, MD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Carcinomatosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: The OSNA technique requires almost 30 minutes. Follow-up time of patients has a mean of 15 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07478107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.