Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT04403867
Status:
RECRUITING
Last Update Posted:
2022-08-17
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D061206', 'term': 'Neoplasm Micrometastasis'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077258', 'term': 'sarcolipin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-15', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival (Disease free survival [DFS], overall survival [OS])', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Evaluation of survival outcomes according to the type and volume of lymph nodal disease'}, {'measure': 'Recurrence rate', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease'}], 'secondaryOutcomes': [{'measure': 'Usage of adjuvant therapy in case of small-volume lymph node disease', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Evaluation of the number of patients receiving or not receiving an adjuvant treatment (radiation therapy, chemotherapy, combinations of the two) in case of small-volume lymph node disease (ITC and micro metastasis)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometrial cancer', 'cervical cancer', 'sentinel lymph node', 'low volume disease', 'survival', 'recurrence rate', 'adjuvant therapy', 'micrometastases', 'isolated tumor cell', 'macrometastases', 'ultrastaging', 'one-step nucleic acid amplification (OSNA)'], 'conditions': ['Endometrial Cancer', 'Cervical Cancer', 'Sentinel Lymph Node', 'Micrometastasis', 'Sentinel Lymph Node Biopsy', 'Endometrium Tumor', 'Endometrial Neoplasms', 'Cervical Neoplasm', 'Cervical Tumor', 'Lymph Node Metastases', 'Lymph Node Disease']}, 'referencesModule': {'references': [{'pmid': '31863354', 'type': 'RESULT', 'citation': 'Gomez-Hidalgo NR, Ramirez PT, Ngo B, Perez-Hoyos S, Coreas N, Sanchez-Iglesias JL, Cabrera S, Franco S, Benavente AP, Gil-Moreno A. Oncologic impact of micrometastases or isolated tumor cells in sentinel lymph nodes of patients with endometrial cancer: a meta-analysis. Clin Transl Oncol. 2020 Aug;22(8):1272-1279. doi: 10.1007/s12094-019-02249-x. Epub 2019 Dec 20.'}, {'pmid': '31345606', 'type': 'RESULT', 'citation': 'Ignatov A, Lebius C, Ignatov T, Ivros S, Knueppel R, Papathemelis T, Ortmann O, Eggemann H. Lymph node micrometastases and outcome of endometrial cancer. Gynecol Oncol. 2019 Sep;154(3):475-479. doi: 10.1016/j.ygyno.2019.07.018. Epub 2019 Jul 22.'}, {'pmid': '30353577', 'type': 'RESULT', 'citation': 'Piedimonte S, Richer L, Souhami L, Arseneau J, Fu L, Gilbert L, Alfieri J, Jardon K, Zeng XZ. Clinical significance of isolated tumor cells and micrometastasis in low-grade, stage I endometrial cancer. J Surg Oncol. 2018 Dec;118(7):1194-1198. doi: 10.1002/jso.25259. Epub 2018 Oct 24.'}, {'pmid': '28577885', 'type': 'RESULT', 'citation': 'Plante M, Stanleigh J, Renaud MC, Sebastianelli A, Grondin K, Gregoire J. Isolated tumor cells identified by sentinel lymph node mapping in endometrial cancer: Does adjuvant treatment matter? Gynecol Oncol. 2017 Aug;146(2):240-246. doi: 10.1016/j.ygyno.2017.05.024. Epub 2017 May 31.'}, {'pmid': '31818860', 'type': 'RESULT', 'citation': 'Goebel EA, St Laurent JD, Nucci MR, Feltmate CM. Retrospective detection of isolated tumor cells by immunohistochemistry in sentinel lymph node biopsy performed for endometrial carcinoma: is there clinical significance? Int J Gynecol Cancer. 2020 Mar;30(3):291-298. doi: 10.1136/ijgc-2019-000934. Epub 2019 Dec 8.'}, {'pmid': '30286945', 'type': 'RESULT', 'citation': 'Aloisi A, Casanova JM, Tseng JH, Seader KA, Nguyen NT, Alektiar KM, Makker V, Chiang S, Soslow RA, Leitao MM Jr, Abu-Rustum NR. Patterns of FIRST recurrence of stage IIIC1 endometrial cancer with no PARAAORTIC nodal assessment. Gynecol Oncol. 2018 Dec;151(3):395-400. doi: 10.1016/j.ygyno.2018.09.021. Epub 2018 Oct 2.'}, {'pmid': '31871114', 'type': 'RESULT', 'citation': 'Nica A, Gien LT, Ferguson SE, Covens A. Does small volume metastatic lymph node disease affect long-term prognosis in early cervical cancer? Int J Gynecol Cancer. 2020 Mar;30(3):285-290. doi: 10.1136/ijgc-2019-000928. Epub 2019 Dec 22.'}, {'pmid': '31450214', 'type': 'RESULT', 'citation': 'Delomenie M, Bonsang-Kitzis H, Bats AS, Ngo C, Balaya V, Xuan HTN, Koual M, Mathevet P, Lecuru F. The clinical implication of lymph nodes micrometastases and isolated tumor cells in patients with cervical cancer: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:71-76. doi: 10.1016/j.ejogrb.2019.08.010. Epub 2019 Aug 19.'}, {'pmid': '30833435', 'type': 'RESULT', 'citation': 'Guani B, Dorez M, Magaud L, Buenerd A, Lecuru F, Mathevet P. Impact of micrometastasis or isolated tumor cells on recurrence and survival in patients with early cervical cancer: SENTICOL Trial. Int J Gynecol Cancer. 2019 Mar;29(3):447-452. doi: 10.1136/ijgc-2018-000089. Epub 2019 Jan 4.'}, {'pmid': '22120175', 'type': 'RESULT', 'citation': 'Cibula D, Abu-Rustum NR, Dusek L, Zikan M, Zaal A, Sevcik L, Kenter GG, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Lacheta J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol Oncol. 2012 Mar;124(3):496-501. doi: 10.1016/j.ygyno.2011.11.037. Epub 2011 Nov 25.'}, {'pmid': '30318103', 'type': 'RESULT', 'citation': 'Cibula D, McCluggage WG. Sentinel lymph node (SLN) concept in cervical cancer: Current limitations and unanswered questions. Gynecol Oncol. 2019 Jan;152(1):202-207. doi: 10.1016/j.ygyno.2018.10.007. Epub 2018 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined.\n\nThis study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed.\n\nThis will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with early stage uterine (endometrial or cervical) cancer, who underwent a sentinel lymph node (SLN) procedure with an identification of lymph nodes metastasis (macrometastasis or low volume disease \\[micrometastasis and isolated tumor cells\\])', 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early stage endometrial cancer scheduled for SLN procedure\n* Early stage cervical cancer scheduled for SLN procedure\n* Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis\n* Presence of lymph nodes metastasis (macrometastasis or low volume disease \\[micrometastasis and isolated tumor cells\\])\n\nExclusion Criteria:\n\n* Previous (\\<5 years) or concomitant malignancy other than non-melanoma skin cancer\n* Advanced/metastatic endometrial cancer\n* Locally advanced/metastatic cervical cancer'}, 'identificationModule': {'nctId': 'NCT04403867', 'acronym': 'ITCMicroUtCa', 'briefTitle': 'The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study', 'orgStudyIdInfo': {'id': 'INT 135/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometrial cancer patients', 'description': 'Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).', 'interventionNames': ['Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy']}, {'label': 'Cervical cancer patients', 'description': 'Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).', 'interventionNames': ['Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy']}], 'interventions': [{'name': 'Sentinel lymph node (SLN) biosy +/- lymphadenectomy', 'type': 'PROCEDURE', 'otherNames': ['Pathological evaluation of lymph nodes (standard H&H + ultrastaging or OSNA)'], 'description': 'Evaluation of type and volume of lymph nodal disease', 'armGroupLabels': ['Cervical cancer patients', 'Endometrial cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Martinelli, MD', 'role': 'CONTACT', 'email': 'fabio.martinelli@istitutotumori.mi.it', 'phone': '+390223903322'}], 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Fabio Martinelli, MD', 'role': 'CONTACT', 'email': 'fabio.martinelli@istitutotumori.mi.it', 'phone': '+390223903322'}], 'overallOfficials': [{'name': 'Fabio Martinelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fabio Martinelli', 'investigatorAffiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}}}}