Endometrial CancerSENT-OSNANCT06935305
OSNA Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer
A study testing OSNA and Ultrastaging in people with Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- OSNA and Ultrastaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,922 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2025to 17 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed endometrial cancer
- Apparent (pre-operative) FIGO stage I-II
- Radical surgery
- Attempt of SLN mapping
Who cannot join
- Uterine sarcoma (including endometrial stromal sarcoma)
- Fertility sparing surgery
- Dedifferentiated histology
- Undifferentiated histology
- Neoadjuvant therapy
- Previous surgery to pelvic lymph nodes
- Lymph nodes with short axis >15 mm at pre-operative imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Francesco Fanfani, +39 0630153421, francesco.fanfani@policlinicogemelli.it
About this study
Official title: One Step Nucleic Acid Amplification (OSNA) Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer: a Randomized, Multicenter, Controlled Trial (SENT-OSNA Study)
Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.
Read the detailed description
This is a non-inferiority randomized trial with the incidence of patients with metastatic SLN as primary endpoint. Based on recent literature, incidence of patients with metastatic SLN detected by ultrastaging has an average value of 11%. Assuming a -4% as the maximum allowable difference in detection rate to declare non-inferiority, a power of 80% and a significance level of 2.5% (one-side) a sample size of 1922 (961 per arm) is needed. Two interim analyses are planned, one after the first 640 and the second after 1280 patients. At the first interim analysis null hypothesis (inferiority of OSNA with respect to ultrastaging) will be rejected at a significance level <0.00010 otherwise the study will go on and at the second analysis the null hypothesis will be rejected at a significance level of 0.0059. The final analysis will use 0.0189 as significance threshold. The O'Brien Fleming alpha spending function was used to define these values.
The primary endpoint is defined as the proportion of patients with positive SLN over the total of randomized patients. This proportion will be reported together with the 95% confidence interval to better identify the range of inferential values. Incidence of isolated tumor cells, micro- and macro-metastasis will be calculated.
Number of copies of CK19 mRNA to define volume of metastases will be adapted from previous reports.
To describe the sample, quantitative variables will be summarized using median and interquartile range while categorical items will be reported as absolute counts and percentages. Patients will be described according the arm they were randomized to. A first analysis will be performed on an Intent-To-Treat basis, considering all randomized patients. A secondary analysis will be performed on the Per-Protocol population.
- Conditions
- Endometrial Cancer
- Being tested
- OSNA, Ultrastaging
- Keywords
- endometrial cancer, OSNA, sentinel lymph node, ultrastaging
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSNADevice
The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method
UltrastagingDevice
The search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method
| Study group | Role | What they receive |
|---|---|---|
| ultrastaging arm | Active comparator | In this study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard) Receives: Device: Ultrastaging |
| OSNA arm | Experimental | In this arm the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method (experimental) Receives: Device: OSNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SLN metastasis detected by OSNA versus ultrastaging method
We will evaluate the number of lymph node metastases identified with both methods, in order to calculate the incidence of lymph node metastases for each group
Measured: From enrollment to the acquisition of the histological examination (8 weeks)
Secondary outcomes (9)
Overall survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.
The aim is to assess the impact of both techniques on staging, prognosis, and therapeutic strategies, optimizing patient management according to molecular subtypes.
Measured: 3 years (a 3-year follow-up is planned)
Disease-free survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.
The aim is to assess the impact of both techniques on staging, prognosis, and therapeutic strategies, optimizing patient management according to molecular subtypes.
Measured: 3 years (a 3-year follow-up is planned)
3 year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients
The study evaluates 3 year disease-free survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
Measured: 3 years (a 3-year follow-up is planned)
3 year overall survival (measured in months) in OSNA versus ultrastaging negative patients
The study evaluates 3 year overall survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
Measured: 3 years (a 3-year follow-up is planned)
5-year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients
The study evaluates 5-year disease-free survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
Measured: 5 years
5-year overall survival (measured in months) in OSNA versus ultrastaging negative patients
The study evaluates 5-year overall survival in endometrial carcinoma patients with negative sentinel lymph nodes (SLN) according to OSNA and ultrastaging. By comparing both techniques, the research aims to determine their prognostic value and potential implications for tailoring post-surgical management and follow-up strategies
Measured: 5 years
Incidence of endosalpingiosis in ultrastaging arm
The study investigates the incidence of endosalpingiosis in the ultrastaging arm of sentinel lymph node analysis in endometrial carcinoma. The aim is to assess its frequency, potential clinical significance, and implications for pathological interpretation and patient management.
Measured: From enrollment to the acquisition of the histological examination (8 weeks)
Total Tumor Load (calculating by summing the number of copies of CK19 from each sentinel lymph node) and correlation with prognosis
The study examines the total tumor load (TTL), defined as the sum of CK19 copies from each sentinel lymph node (SLN), and its correlation with prognosis.
Measured: 3 years (a 3-year follow-up is planned)
Dimension of SLN (measured in millimeters) metastases at ultrastaging and correlation with prognosis
The study analyzes the size of sentinel lymph node (SLN) metastases detected through ultrastaging and its correlation with prognosis in endometrial carcinoma. The objective is to evaluate the prognostic significance of metastasis dimensions and their potential impact on clinical management and treatment decisions.
Measured: 3 years (a 3-year follow-up is planned)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start30 Jul 2025
- Primary completion17 Sep 2026 (estimated)
- Study completion17 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.
- Masking
- None (open label)
- Enrolment
- 1,922 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex Europe GmbH
- Responsible party
- Principal investigator, Fanfani Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Francesco Fanfani, Professor, Principal investigator, Fondazione Policlinico Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935305
- Sponsor's protocol ID
- 7170
- Acronym
- SENT-OSNA
- Status last verified
- Dec 2024
- First submitted
- 9 Feb 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marchocki Z, Cusimano MC, Clarfield L, Kim SR, Fazelzad R, Espin-Garcia O, Bouchard-Fortier G, Rossi EC, Stewart KI, Soliman PT, How JA, Gotlieb WH, Holloway RW, Ianieri MM, Cabrera S, Lim YK, Ferguson SE. Sentinel lymph node biopsy in high-grade endometrial cancer: a systematic review and meta-analysis of performance characteristics. Am J Obstet Gynecol. 2021 Oct;225(4):367.e1-367.e39. doi: 10.1016/j.ajog.2021.05.034. Epub 2021 May 29.
PubMed 34058168Persson J, Salehi S, Bollino M, Lonnerfors C, Falconer H, Geppert B. Pelvic Sentinel lymph node detection in High-Risk Endometrial Cancer (SHREC-trial)-the final step towards a paradigm shift in surgical staging. Eur J Cancer. 2019 Jul;116:77-85. doi: 10.1016/j.ejca.2019.04.025. Epub 2019 Jun 7.
PubMed 31181536Koh WJ, Abu-Rustum NR, Bean S, Bradley K, Campos SM, Cho KR, Chon HS, Chu C, Cohn D, Crispens MA, Damast S, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, George S, Han E, Higgins S, Huh WK, Lurain JR 3rd, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Ueda S, Wyse E, Yashar CM, McMillian NR, Scavone JL. Uterine Neoplasms, Version 1.2018, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2018 Feb;16(2):170-199. doi: 10.6004/jnccn.2018.0006.
PubMed 29439178Bodurtha Smith AJ, Fader AN, Tanner EJ. Sentinel lymph node assessment in endometrial cancer: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 May;216(5):459-476.e10. doi: 10.1016/j.ajog.2016.11.1033. Epub 2016 Nov 18.
PubMed 27871836Bogani G, Murgia F, Ditto A, Raspagliesi F. Sentinel node mapping vs. lymphadenectomy in endometrial cancer: A systematic review and meta-analysis. Gynecol Oncol. 2019 Jun;153(3):676-683. doi: 10.1016/j.ygyno.2019.03.254. Epub 2019 Apr 2.
PubMed 30952370Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.
PubMed 33397713Lortet-Tieulent J, Ferlay J, Bray F, Jemal A. International Patterns and Trends in Endometrial Cancer Incidence, 1978-2013. J Natl Cancer Inst. 2018 Apr 1;110(4):354-361. doi: 10.1093/jnci/djx214.
PubMed 29045681Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
PubMed 33433946Bizzarri N, Giuliano MC, Parisi G, Pirrelli F, Giannarelli D, Perrone E, Dinoi G, Capasso I, Querleu D, Zannoni GF, Cucinella G, Zapardiel I, Vizzielli G, Fagotti A, Fanfani F. One-step nucleic acid amplification versus ultra-staging to detect sentinel lymph node metastasis in endometrial cancer: a randomized, multi-center, controlled trial (SENT-OSNA Trial). Int J Gynecol Cancer. 2026 Feb 16:104601. doi: 10.1016/j.ijgc.2026.104601. Online ahead of print.
PubMed 41794557
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Step Nucleic Acid Amplification (OSNA) Versus Ultrastaging to Detect Sentinel Lymph Node Metastasis in Endometrial Cancer: a Randomized, Multicenter, Controlled Trial (SENT-OSNA Study)
- ClinicalTrials.gov ID
- NCT06935305
- Acronym / sponsor ID
- SENT-OSNA / 7170
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, OSNA, sentinel lymph node, ultrastaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,922 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Sysmex Europe GmbH
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 17 Sep 2026 (estimated)
- Study completion
- 17 Mar 2029 (estimated)
- First posted
- 20 Apr 2025 (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.
Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.
Detailed description
This is a non-inferiority randomized trial with the incidence of patients with metastatic SLN as primary endpoint. Based on recent literature, incidence of patients with metastatic SLN detected by ultrastaging has an average value of 11%. Assuming a -4% as the maximum allowable difference in detection rate to declare non-inferiority, a power of 80% and a significance level of 2.5% (one-side) a sample size of 1922 (961 per arm) is needed. Two interim analyses are planned, one after the first 640 and the second after 1280 patients. At the first interim analysis null hypothesis (inferiority of OSNA with respect to ultrastaging) will be rejected at a significance level <0.00010 otherwise the study will go on and at the second analysis the null hypothesis will be rejected at a significance level of 0.0059. The final analysis will use 0.0189 as significance threshold. The O'Brien Fleming alpha spending function was used to define these values.
The primary endpoint is defined as the proportion of patients with positive SLN over the total of randomized patients. This proportion will be reported together with the 95% confidence interval to better identify the range of inferential values. Incidence of isolated tumor cells, micro- and macro-metastasis will be calculated.
Number of copies of CK19 mRNA to define volume of metastases will be adapted from previous reports.
To describe the sample, quantitative variables will be summarized using median and interquartile range while categorical items will be reported as absolute counts and percentages. Patients will be described according the arm they were randomized to. A first analysis will be performed on an Intent-To-Treat basis, considering all randomized patients. A secondary analysis will be performed on the Per-Protocol population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the OSNA method.
| Arm | Type | Receives |
|---|---|---|
| ultrastaging arm | Active comparator | Device: UltrastagingIn this study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard) |
| OSNA arm | Experimental | Device: OSNAIn this arm the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method (experimental) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed endometrial cancer
- Apparent (pre-operative) FIGO stage I-II
- Radical surgery
- Attempt of SLN mapping
Key exclusion criteria (7 listed)
- Uterine sarcoma (including endometrial stromal sarcoma)
- Fertility sparing surgery
- Dedifferentiated histology
- Undifferentiated histology
- Neoadjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSNAThe search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the OSNA method | Device | OSNA arm |
| UltrastagingThe search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method | Device | ultrastaging arm |
Primary outcome
Number of SLN metastasis detected by OSNA versus ultrastaging method
Time frame: From enrollment to the acquisition of the histological examination (8 weeks)
We will evaluate the number of lymph node metastases identified with both methods, in order to calculate the incidence of lymph node metastases for each group
9 secondary outcomes
Overall survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.
Time frame: 3 years (a 3-year follow-up is planned)
Disease-free survival (measured in months) in patients with a diagnosis of lymph node metastases (identified with OSNA and ultrastaging), performing stratification by molecular class.
Time frame: 3 years (a 3-year follow-up is planned)
3 year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients
Time frame: 3 years (a 3-year follow-up is planned)
3 year overall survival (measured in months) in OSNA versus ultrastaging negative patients
Time frame: 3 years (a 3-year follow-up is planned)
5-year disease-free survival (measured in months) in OSNA versus ultrastaging negative patients
Time frame: 5 years
5-year overall survival (measured in months) in OSNA versus ultrastaging negative patients
Time frame: 5 years
Incidence of endosalpingiosis in ultrastaging arm
Time frame: From enrollment to the acquisition of the histological examination (8 weeks)
Total Tumor Load (calculating by summing the number of copies of CK19 from each sentinel lymph node) and correlation with prognosis
Time frame: 3 years (a 3-year follow-up is planned)
Dimension of SLN (measured in millimeters) metastases at ultrastaging and correlation with prognosis
Time frame: 3 years (a 3-year follow-up is planned)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 34058168Marchocki Z, Cusimano MC, Clarfield L, Kim SR, Fazelzad R, Espin-Garcia O, Bouchard-Fortier G, Rossi EC, Stewart KI, Soliman PT, How JA, Gotlieb WH, Holloway RW, Ianieri MM, Cabrera S, Lim YK, Ferguson SE. Sentinel lymph node biopsy in high-grade endometrial cancer: a systematic review and meta-analysis of performance characteristics. Am J Obstet Gynecol. 2021 Oct;225(4):367.e1-367.e39. doi: 10.1016/j.ajog.2021.05.034. Epub 2021 May 29.
- Background: PubMed 31181536Persson J, Salehi S, Bollino M, Lonnerfors C, Falconer H, Geppert B. Pelvic Sentinel lymph node detection in High-Risk Endometrial Cancer (SHREC-trial)-the final step towards a paradigm shift in surgical staging. Eur J Cancer. 2019 Jul;116:77-85. doi: 10.1016/j.ejca.2019.04.025. Epub 2019 Jun 7.
- Background: PubMed 29439178Koh WJ, Abu-Rustum NR, Bean S, Bradley K, Campos SM, Cho KR, Chon HS, Chu C, Cohn D, Crispens MA, Damast S, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, George S, Han E, Higgins S, Huh WK, Lurain JR 3rd, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Fader AN, Remmenga SW, Reynolds RK, Tillmanns T, Ueda S, Wyse E, Yashar CM, McMillian NR, Scavone JL. Uterine Neoplasms, Version 1.2018, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2018 Feb;16(2):170-199. doi: 10.6004/jnccn.2018.0006.
- Background: PubMed 27871836Bodurtha Smith AJ, Fader AN, Tanner EJ. Sentinel lymph node assessment in endometrial cancer: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 May;216(5):459-476.e10. doi: 10.1016/j.ajog.2016.11.1033. Epub 2016 Nov 18.
- Background: PubMed 30952370Bogani G, Murgia F, Ditto A, Raspagliesi F. Sentinel node mapping vs. lymphadenectomy in endometrial cancer: A systematic review and meta-analysis. Gynecol Oncol. 2019 Jun;153(3):676-683. doi: 10.1016/j.ygyno.2019.03.254. Epub 2019 Apr 2.
- Background: PubMed 33397713Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.
- Background: PubMed 29045681Lortet-Tieulent J, Ferlay J, Bray F, Jemal A. International Patterns and Trends in Endometrial Cancer Incidence, 1978-2013. J Natl Cancer Inst. 2018 Apr 1;110(4):354-361. doi: 10.1093/jnci/djx214.
- Background: PubMed 33433946Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
- Derived from this study: PubMed 41794557Bizzarri N, Giuliano MC, Parisi G, Pirrelli F, Giannarelli D, Perrone E, Dinoi G, Capasso I, Querleu D, Zannoni GF, Cucinella G, Zapardiel I, Vizzielli G, Fagotti A, Fanfani F. One-step nucleic acid amplification versus ultra-staging to detect sentinel lymph node metastasis in endometrial cancer: a randomized, multi-center, controlled trial (SENT-OSNA Trial). Int J Gynecol Cancer. 2026 Feb 16:104601. doi: 10.1016/j.ijgc.2026.104601. Online ahead of print.
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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.
Francesco Fanfani, Professor principal investigator
Fondazione Policlinico Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSNA and Ultrastaging in people with Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Fanfani, Professor (+390630153421, francesco.fanfani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SLN metastasis detected by OSNA versus ultrastaging method (time frame: From enrollment to the acquisition of the histological examination (8 weeks)). 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 NCT06935305, which also lists 9 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 18 Nov 2025.