Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06689956
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2024-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2024-11-13', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival (RFS)', 'timeFrame': 'Up to 5 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Non-vaginal RFS', 'timeFrame': 'Up to 5 years', 'description': '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.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 5 years', 'description': 'Overall survival is defined as the time from surgery to death due to any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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']}, 'referencesModule': {'references': [{'pmid': '40148176', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. 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.\n\nOUTLINE: This is an observational study.\n\nPatients undergo tissue sample collection and have their medical records reviewed on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with low-risk endometrial cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\n * Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging.\n * Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or \\< 200 cells)\n * No adjuvant treatment after surgery\n * Research consent provided.\n\nExclusion Criteria:\n\n* Prior neoadjuvant chemotherapy.\n\n * Planning to receive adjuvant treatment.\n * Presence of synchronous cancer (excluding non-melanoma skin cancer).\n * Extent of disease in SLN: micrometastasis (\\> 0.2 to ≤ 2.0 mm) or macrometastasis (\\> 2.0 mm).\n * Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology.\n * Prior invasive cancer diagnosis within 5 years of study entry (excluding non-melanoma skin cancer).'}, 'identificationModule': {'nctId': 'NCT06689956', 'briefTitle': 'Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study', 'orgStudyIdInfo': {'id': '23-008963'}, 'secondaryIdInfos': [{'id': 'NCI-2024-09016', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '23-008963', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rochester'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo tissue sample collection and have their medical records reviewed on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-Interventional Study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Gretchen E. Glaser, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christian Dagher', 'role': 'CONTACT', 'email': 'dagherc@mskcc.org', 'phone': '347-798-9213'}, {'name': 'Nadeem R. Abu-Rustum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Behrouz Zand', 'role': 'CONTACT', 'email': 'bzand@houstonmethodist.org', 'phone': '713-790-3311'}, {'name': 'Pedro T. Ramirez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Stephan Polterauer', 'role': 'CONTACT', 'email': 'stephan.polterauer@meduniwien.ac.at', 'phone': '+43 1 401600'}, {'name': 'Christoph Grimm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Louise De Brot', 'role': 'CONTACT', 'email': 'louise.andrade@accamargo.org.br', 'phone': '+55 11 2189-5000'}, {'name': 'Glauco Baiocchi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AC Camargo Cancer Center', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stephanie Gill', 'role': 'CONTACT', 'email': 'zdis-stephanie.gill@uhn.ca', 'phone': '+1 416-480-6100'}, {'name': 'Allan Covens, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lara DeGuerke', 'role': 'CONTACT', 'email': 'lara.deguerke@gmail.com', 'phone': '+1 514-252-3400'}, {'name': 'Sabrina Piedimonte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Maisonneuve Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '31100', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alejandra Martinez', 'role': 'CONTACT', 'email': 'martinez.alejandra@iuct-oncopole.fr', 'phone': '+33 5 31 15 50 50'}, {'name': 'Giulio Ricotta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Universitaire du Cancer Toulouse Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '45147', 'city': 'Essen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rainer Kimmig', 'role': 'CONTACT', 'email': 'Rainer.Kimmig@uk-essen.de', 'phone': '+49 201 7230'}, {'name': 'Paul Buderath, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Kefar Sava', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yfat Kadan', 'role': 'CONTACT', 'email': 'yfat_ka@clalit.org.il', 'phone': '+972 9-747-2555'}, {'name': 'Mario Beiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center, Faculty of Medicine - Tel-Aviv University', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '12060', 'city': 'Verduno', 'state': 'CN', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jessica Mauro', 'role': 'CONTACT', 'email': 'jmauro@aslcn2.it', 'phone': '+39 0173 316111'}, {'name': 'Alessandro Buda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Michele e Pietro Ferrero', 'geoPoint': {'lat': 44.66614, 'lon': 7.93074}}, {'zip': '20900', 'city': 'Monza', 'state': 'MB', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tommaso Grassi', 'role': 'CONTACT', 'email': 'grassi.tommaso88@gmail.com', 'phone': '+39 2331'}, {'name': 'Fabio Landon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Fondazione San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giorgio Bogani', 'role': 'CONTACT', 'email': 'giorgio.bogani@istitutotumori.mi.it', 'phone': '+39 02 23901'}, {'name': 'Francesco Raspagliesi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Istituto Nazionale Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'state': 'MI', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriella Schivardi', 'role': 'CONTACT', 'email': 'gabriella.schivardi@ieo.it', 'phone': '+39 02 574891'}, {'name': 'Francesco Multinu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00168', 'city': 'Roma', 'state': 'RM', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ilaria Capasso', 'role': 'CONTACT', 'email': 'capasso.ilaria@mayo.edu', 'phone': '+39 06 30151'}, {'name': 'Francesco Fanfani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Universitario Fondazione Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '33100', 'city': 'Udine', 'state': 'UD', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tommaso Occhiali', 'role': 'CONTACT', 'email': 'tommaso.occhiali@gmail.com', 'phone': '+39 0432 556111'}, {'name': 'Giuseppe Vizzielli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '80131', 'city': 'Naples', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Cucinella', 'role': 'CONTACT', 'email': 'giuseppecucinella@outlook.com', 'phone': '+39 081 590 3111'}, {'name': 'Vito Chiantera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '35016', 'city': 'Las Palmas', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Beatriz Navarro', 'role': 'CONTACT', 'email': 'bea_0904@hotmail.com', 'phone': '+34 928 44 45 00'}, {'name': 'Octavio Arencibia Sanchez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Materno of Las Palmas', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}, {'zip': '28029', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alicia Hernandez', 'role': 'CONTACT', 'email': 'aliciahernandezg@gmail.com', 'phone': '+34 917 27 75 76'}, {'name': 'Ignacio Zapardiel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '6900', 'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Andrea Papadia, MD, PhD', 'role': 'CONTACT', 'email': 'andrea.papadia@eoc.ch', 'phone': '091 811 61 58'}, {'name': 'Andrea Papadia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Regionale di Lugano, Civico', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'Gretchen E. Glaser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}