FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaNCT06689956
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
An observational study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, run by Mayo Clinic at 20 sites in 10 countries.
Trial summary
This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Stage IA1 Endometrial Cancer FIGO 2023
- What is being tested?
- Non-Interventional Study
- How many people
- 212 participants
- Where
- 20 sitesin 10 countries
- Study dates
- 4 Dec 2024to 31 Oct 2029
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with low-risk endometrial cancer.
Who may be able to join
- Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (< 5 vessels involved) will be included.
- Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging.
- Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or < 200 cells)
- No adjuvant treatment after surgery
- Research consent provided.
Who cannot join
- Prior neoadjuvant chemotherapy.
- Planning to receive adjuvant treatment.
- Presence of synchronous cancer (excluding non-melanoma skin cancer).
- Extent of disease in SLN: micrometastasis (> 0.2 to ≤ 2.0 mm) or macrometastasis (> 2.0 mm).
- Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology.
- Prior invasive cancer diagnosis within 5 years of study entry (excluding non-melanoma skin cancer).
Trial locations and contacts
20 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 10 countries
Italy7 sites, 7 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale Tumori
Milan, MI, 20133
Giorgio Bogani, +39 02 23901, giorgio.bogani@istitutotumori.mi.it
Francesco Raspagliesi, MD
- Recruiting
European Institute of Oncology
Milan, MI, 20141
Gabriella Schivardi, +39 02 574891, gabriella.schivardi@ieo.it
Francesco Multinu, MD
- Not yet recruiting
IRCCS Fondazione San Gerardo dei Tintori
Monza, MB, 20900
Tommaso Grassi, +39 2331, grassi.tommaso88@gmail.com
Fabio Landon, MD
- Not yet recruiting
Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
Naples, 80131
Giuseppe Cucinella, +39 081 590 3111, giuseppecucinella@outlook.com
Vito Chiantera, MD
- Recruiting
Policlinico Universitario Fondazione Agostino Gemelli
Roma, RM, 00168
Ilaria Capasso, +39 06 30151, capasso.ilaria@mayo.edu
Francesco Fanfani, MD
- Not yet recruiting
University of Udine
Udine, UD, 33100
Tommaso Occhiali, +39 0432 556111, tommaso.occhiali@gmail.com
Giuseppe Vizzielli, MD, PhD
- Not yet recruiting
Ospedale Michele e Pietro Ferrero
Verduno, CN, 12060
Jessica Mauro, +39 0173 316111, jmauro@aslcn2.it
Alessandro Buda, MD
United States3 sites, 3 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Behrouz Zand, 713-790-3311, bzand@houstonmethodist.org
Pedro T. Ramirez, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Christian Dagher, 347-798-9213, dagherc@mskcc.org
Nadeem R. Abu-Rustum, MD
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Gretchen E. Glaser, MD
Canada2 sites, 2 recruiting
- Recruiting
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Lara DeGuerke, +1 514-252-3400, lara.deguerke@gmail.com
Sabrina Piedimonte, MD
- Recruiting
Sunnybrook Health Sciences, University of Toronto
Toronto, Ontario, M4N 3M5
Stephanie Gill, +1 416-480-6100, zdis-stephanie.gill@uhn.ca
Allan Covens, MD
Spain2 sites, 2 recruiting
- Recruiting
Hospital Materno Infantil Las Palmas
Las Palmas, 35016
Beatriz Navarro, +34 928 44 45 00, bea_0904@hotmail.com
Octavio Arencibia Sanchez, MD, PhD
- Recruiting
Hospital Universitario La Paz
Madrid, 28029
Alicia Hernandez, +34 917 27 75 76, aliciahernandezg@gmail.com
Ignacio Zapardiel, MD
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Stephan Polterauer, +43 1 401600, stephan.polterauer@meduniwien.ac.at
Christoph Grimm, MD
Brazil1 site, 1 recruiting
- Recruiting
AC Camargo Cancer Center
São Paulo
Louise De Brot, +55 11 2189-5000, louise.andrade@accamargo.org.br
Glauco Baiocchi, MD, PhD
France1 site, 1 recruiting
- Not yet recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31100
Alejandra Martinez, +33 5 31 15 50 50, martinez.alejandra@iuct-oncopole.fr
Giulio Ricotta, MD
Germany1 site, 1 recruiting
- Not yet recruiting
University Hospital Essen
Essen, 45147
Rainer Kimmig, +49 201 7230, Rainer.Kimmig@uk-essen.de
Paul Buderath, MD
Israel1 site, 1 recruiting
- Not yet recruiting
Meir Medical Center, Faculty of Medicine - Tel-Aviv University
Kefar Sava
Yfat Kadan, +972 9-747-2555, yfat_ka@clalit.org.il
Mario Beiner, MD
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale di Lugano, Civico
Lugano, 6900
Andrea Papadia, MD, PhD, 091 811 61 58, andrea.papadia@eoc.ch
Andrea Papadia, MD, PhD
About this study
Official title: Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate whether the likelihood of disease recurrence differs between a prospective cohort of patients with low-risk endometrial cancer with ITC and an historical cohort with negative SLNs.
OUTLINE: This is an observational study.
Patients undergo tissue sample collection and have their medical records reviewed on study.
- Conditions
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Stage IA1 Endometrial Cancer FIGO 2023, Stage IA2 Endometrial Cancer FIGO 2023
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo tissue sample collection and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
RFS is defined as the length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. (Recurrence may be vaginal, hematogenous, lymphatic, or peritoneal.) RFS will be measured from the date of surgery to the date of recurrence, death, or last disease evaluation.
Measured: Up to 5 years
Secondary outcomes (2)
Non-vaginal RFS
Non-vaginal RFS is defined as the interval from the date of surgery to the date of the first of the following events: non-vaginal recurrence or death due to any cause.
Measured: Up to 5 years
Overall Survival (OS)
Overall survival is defined as the time from surgery to death due to any cause.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start4 Dec 2024
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gretchen E. Glaser, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689956
- Sponsor's protocol ID
- 23-008963
- Other IDs
- NCI-2024-09016, 23-008963
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Vitis LA, Bogani G, Raspagliesi F, Arencibia Sanchez O, Navarro B, Multinu F, Zanagnolo V, Baiocchi G, De Brot L, Fanfani F, Capasso I, Piedimonte S, DeGuerke L, Buda A, Mauro J, Alessio M, Filipello F, Beiner M, Kadan Y, Papadia A, Vizzielli G, Restaino S, Grassi T, Landoni F, Bianchi T, Grimm C, Polterauer S, Ricotta G, Martinez A, Buderath P, Kimmig R, Chiantera V, Zand B, Zapardiel I, Hernandez A, Gill S, Covens A, Dagher C, Meschini T, Cucinella G, Schivardi G, Occhiali T, Lembo A, Palmieri E, Shahi M, Fought AJ, McGree ME, Suman VJ, Abu-Rustum NR, Ramirez PT, Mariani A, Glaser GE; Low Volume Metastasis in Endometrial Cancer Consortium. Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: a prospective, multi-center, single-arm, observational study (ENDO-ITC study). Int J Gynecol Cancer. 2025 Aug;35(8):101764. doi: 10.1016/j.ijgc.2025.101764. Epub 2025 Mar 7.
PubMed 40148176
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
- ClinicalTrials.gov ID
- NCT06689956
- Acronym / sponsor ID
- 23-008963
- Conditions
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Stage IA1 Endometrial Cancer FIGO 2023, Stage IA2 Endometrial Cancer FIGO 2023
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 15 Nov 2024 (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.
This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate whether the likelihood of disease recurrence differs between a prospective cohort of patients with low-risk endometrial cancer with ITC and an historical cohort with negative SLNs.
OUTLINE: This is an observational study.
Patients undergo tissue sample collection and have their medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo tissue sample collection and have their medical records reviewed on study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with low-risk endometrial cancer.
Key inclusion criteria (5 listed)
- Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (< 5 vessels involved) will be included.
Key exclusion criteria (6 listed)
- Prior neoadjuvant chemotherapy.
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 |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Observational |
Primary outcome
Recurrence-free survival (RFS)
Time frame: Up to 5 years
RFS is defined as the length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. (Recurrence may be vaginal, hematogenous, lymphatic, or peritoneal.) RFS will be measured from the date of surgery to the date of recurrence, death, or last disease evaluation.
2 secondary outcomes
Non-vaginal RFS
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
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 19 Feb 2026.
- Derived from this study: PubMed 40148176De Vitis LA, Bogani G, Raspagliesi F, Arencibia Sanchez O, Navarro B, Multinu F, Zanagnolo V, Baiocchi G, De Brot L, Fanfani F, Capasso I, Piedimonte S, DeGuerke L, Buda A, Mauro J, Alessio M, Filipello F, Beiner M, Kadan Y, Papadia A, Vizzielli G, Restaino S, Grassi T, Landoni F, Bianchi T, Grimm C, Polterauer S, Ricotta G, Martinez A, Buderath P, Kimmig R, Chiantera V, Zand B, Zapardiel I, Hernandez A, Gill S, Covens A, Dagher C, Meschini T, Cucinella G, Schivardi G, Occhiali T, Lembo A, Palmieri E, Shahi M, Fought AJ, McGree ME, Suman VJ, Abu-Rustum NR, Ramirez PT, Mariani A, Glaser GE; Low Volume Metastasis in Endometrial Cancer Consortium. Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: a prospective, multi-center, single-arm, observational study (ENDO-ITC study). Int J Gynecol Cancer. 2025 Aug;35(8):101764. doi: 10.1016/j.ijgc.2025.101764. Epub 2025 Mar 7.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Gretchen E. Glaser, MD principal investigator
Mayo Clinic in Rochester
20 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, run by Mayo Clinic at 20 sites in 10 countries.
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 5 inclusion and 6 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy, United States, Canada, Spain, Austria and 5 more countries. 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: Up to 5 years). 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 NCT06689956, which also lists 1 linked publication.
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 19 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.