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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-09016 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-008963 | Other Identifier | Mayo Clinic in Rochester |
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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.
PRIMARY OBJECTIVE:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo tissue sample collection and have their medical records reviewed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
| Overall Survival (OS) |
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Inclusion Criteria:
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.
Exclusion Criteria:
Prior neoadjuvant chemotherapy.
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Patients diagnosed with low-risk endometrial cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gretchen E. Glaser, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40148176 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Tissue samples will be collected from sentinel lymph nodes (SLN) biopsy and uterine tumor removed during planned surgery that are not needed for clinical care.
Overall survival is defined as the time from surgery to death due to any cause.
| Up to 5 years |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| Medical University of Vienna | Recruiting | Vienna | Austria |
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| AC Camargo Cancer Center | Recruiting | São Paulo | Brazil |
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| Sunnybrook Health Sciences, University of Toronto | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| Hopital Maisonneuve Rosemont | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
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| Institut Universitaire du Cancer Toulouse Oncopole | Not yet recruiting | Toulouse | 31100 | France |
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| University Hospital Essen | Not yet recruiting | Essen | 45147 | Germany |
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| Meir Medical Center, Faculty of Medicine - Tel-Aviv University | Not yet recruiting | Kefar Sava | Israel |
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| Ospedale Michele e Pietro Ferrero | Not yet recruiting | Verduno | CN | 12060 | Italy |
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| IRCCS Fondazione San Gerardo dei Tintori | Not yet recruiting | Monza | MB | 20900 | Italy |
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| Fondazione IRCCS Istituto Nazionale Tumori | Recruiting | Milan | MI | 20133 | Italy |
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| European Institute of Oncology | Recruiting | Milan | MI | 20141 | Italy |
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| Policlinico Universitario Fondazione Agostino Gemelli | Recruiting | Roma | RM | 00168 | Italy |
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| University of Udine | Not yet recruiting | Udine | UD | 33100 | Italy |
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| Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale | Not yet recruiting | Naples | 80131 | Italy |
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| Hospital Materno Infantil Las Palmas | Recruiting | Las Palmas | 35016 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | 28029 | Spain |
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| Ospedale Regionale di Lugano, Civico | Recruiting | Lugano | 6900 | Switzerland |
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