Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-03-09 @ 1:13 PM
Study NCT ID:
NCT03386734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2017-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], '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': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 989}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2017-12-15', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'Year 3', 'description': 'Composite outcome: the time interval between randomization and recurrence (local/distant) or second cancer or death (all causes), whichever occurs first.\n\nThis time interval will be analysed concomitantly with HR-QoL scores as a composite outcome.'}, {'measure': 'Health-related quality of life (HR-QoL)', 'timeFrame': 'Year 3', 'description': 'Composite outcome: significant deterioration will specifically be assessed through 3 targeted dimensions (pain score, global health score and physical functioning scores) in EORTC QLQ-C30 and QLQ-CX24 questionnaires.\n\nThese scores will be analysed concomitantly with DFS as a composite outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '37650664', 'type': 'DERIVED', 'citation': 'Boisen M, Guido R. Emerging Treatment Options for Cervical Dysplasia and Early Cervical Cancer. Clin Obstet Gynecol. 2023 Sep 1;66(3):500-515. doi: 10.1097/GRF.0000000000000790. Epub 2023 Jul 25.'}, {'pmid': '30898938', 'type': 'DERIVED', 'citation': 'Lecuru FR, McCormack M, Hillemanns P, Anota A, Leitao M, Mathevet P, Zweemer R, Fujiwara K, Zanagnolo V, Zahl Eriksson AG, Hudson E, Ferron G, Plante M. SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study. Int J Gynecol Cancer. 2019 May;29(4):829-834. doi: 10.1136/ijgc-2019-000332. Epub 2019 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).\n\nThere will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons\' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nI 1. Patient must be ≥ 18 years old, I 2. With squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), I 4. Maximum diameter ≤ 40 mm by clinical examination and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.\n\nExclusion Criteria:\n\nE 1. Pregnancy, E 2. Previous pelvic or abdominal cancer, E 3. Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted), E 4. Proven allergy to blue dye, isotope or indocyanine green (ICG) E 5. Other malignancy within the last 5 years except for treated cancer free of disease and treatment, E 6. Patients with synchronous cancer'}, 'identificationModule': {'nctId': 'NCT03386734', 'acronym': 'SENTICOLIII', 'briefTitle': 'International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer', 'orgStudyIdInfo': {'id': 'N/2016/72'}, 'secondaryIdInfos': [{'id': 'ENGOT-Cx4', 'type': 'OTHER', 'domain': 'ENGOT'}, {'id': 'GINECO-CE106', 'type': 'OTHER', 'domain': 'GINECO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLN biopsy only', 'description': 'Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.', 'interventionNames': ['Procedure: SLN biopsy only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLN biopsy + PLN dissection', 'description': 'SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.', 'interventionNames': ['Procedure: SLN biopsy + PLN dissection']}], 'interventions': [{'name': 'SLN biopsy only', 'type': 'PROCEDURE', 'description': 'In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.', 'armGroupLabels': ['SLN biopsy only']}, {'name': 'SLN biopsy + PLN dissection', 'type': 'PROCEDURE', 'description': 'In active comparator arm, SLN dissection + full lymphadenectomy will be performed.', 'armGroupLabels': ['SLN biopsy + PLN dissection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHC MontLégia', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Erasto Gaertner', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '79085-039', 'city': 'Campo Grande', 'country': 'Brazil', 'facility': 'Barretos Cancer Hospital', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}, {'zip': '3709', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Brazilian National Cancer Institute', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01525-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'AC Camargo Cancer Center - Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Amaral Carvalho de Jaù', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'QC H1T 2M4', 'city': 'Montreal', 'country': 'Canada', 'facility': "CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'country': 'Canada', 'facility': "CHUM Centre Hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'CHU Québec (Hôtel Dieu)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Regina', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre (CASA)', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'city': 'Saskatoon', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre.(CASS)', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': 'J1G 1B1', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': "CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'BC V5Z 1M9', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Cancer Hospital of University of Chinese Academy of Science', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '325015', 'city': 'Wenzhou', 'country': 'China', 'facility': 'The 1st Affiliated Hospital', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '779 00', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '708 00', 'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'University Hospital Ostrava'}, {'zip': '128 51', 'city': 'Prague', 'country': 'Czechia', 'facility': 'General University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '180-81', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Bulovka', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '97400', 'city': 'Saint-Denis', 'state': 'La Réunion', 'country': 'France', 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '77420', 'city': 'Paris', 'state': 'Marne-le-Vallée', 'country': 'France', 'facility': "Grand Hôpital de l'Est Francilien", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Amiens', 'country': 'France', 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Clinique Tivoli-Ducos', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Center de Lutte Contre le Cancer François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '92140', 'city': 'Clamart', 'country': 'France', 'facility': 'Hôpital Antoine Béclère', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre de Lutte Contre le Cancer Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': "CHU de Clermont-Ferrand - 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{'zip': '34125', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Klinikum Kassel', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein, Campus Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '81336', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '18059', 'city': 'Rostock', 'country': 'Germany', 'facility': 'UFK am Klinikum Südstradt Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitaätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89075', 'city': 'Ulm', 'country': 'Germany', 'facility': 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