Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-02 @ 12:57 AM
Study NCT ID:
NCT01639820
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2010-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'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'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2012-07-12', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months', 'timeFrame': '6 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery', 'timeFrame': '30 days, 3 months and 6 months after surgery'}, {'measure': 'the costs of both studied strategies', 'timeFrame': 'At the surgery until 6 months'}, {'measure': 'the detection rate of the sentinel node technique in the 2 arms', 'timeFrame': 'Day 1'}, {'measure': 'the false negative rate in the control arm', 'timeFrame': 'Day 1'}, {'measure': 'the sites of recurrence for each strategy', 'timeFrame': 'Day 1'}, {'measure': 'Number of patients without 3 years-recurrence for each strategy', 'timeFrame': '3 years after surgery'}, {'measure': 'Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node', 'timeFrame': '30 days, 3 months and 6 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical cancer', 'early stage carcinoma', 'FIGO IA1 IA2 IB1 IIA', 'sentinel lymph node biopsy', 'pelvic lymphadenectomy', 'Surgery of uterine cervical carcinoma', 'medico economic impact', 'quality of life'], 'conditions': ['Uterine Cervical Dysplasia']}, 'referencesModule': {'references': [{'pmid': '25727652', 'type': 'RESULT', 'citation': 'Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26.'}, {'pmid': '33773275', 'type': 'RESULT', 'citation': 'Mathevet P, Lecuru F, Uzan C, Boutitie F, Magaud L, Guyon F, Querleu D, Fourchotte V, Baron M, Bats AS; Senticol 2 group. Sentinel lymph node biopsy and morbidity outcomes in early cervical cancer: Results of a multicentre randomised trial (SENTICOL-2). Eur J Cancer. 2021 May;148:307-315. doi: 10.1016/j.ejca.2021.02.009. Epub 2021 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.\n\nThe experimental arm is only sentinel node identification + radical hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 years of age or older,\n* Absence of contraindication to laparoscopy,\n* Uterine cervical carcinoma (every histological type except neuroendocrine),\n* Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),\n* Negative pregnancy test for women able to procreate,\n* Having the French National Social Security\n* Signed informed consent\n\nExclusion Criteria:\n\n* Neuroendocrine carcinoma,\n* In situ carcinoma or stage IA1 without LVSI,\n* Maximal tumoral diameter measured by MRI more than 4 cm,\n* Stage IB1 by "down-staging",\n* Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,\n* Presence of distant metastases,\n* Progression of the cervical cancer or recurrence,\n* History of pelvic lymphadenectomy,\n* Other cancer diagnosed during the course of treatment,\n* Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,\n* History of severe allergy (history of Quincke\'s edema, anaphylactic shock),\n* Patient who does not understand, speak or write the French language,\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT01639820', 'acronym': 'SENTICOL2', 'briefTitle': 'Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts', 'orgStudyIdInfo': {'id': '2008.515'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strategy A', 'description': 'Only identification of sentinel nodes (without pelvic lymph-node dissection)', 'interventionNames': ['Procedure: only identification of sentinel nodes (without pelvic lymph-node dissection)']}, {'type': 'OTHER', 'label': 'Strategy B', 'description': 'Identification of sentinel nodes + full pelvic lymph-node dissection', 'interventionNames': ['Procedure: identification of sentinel nodes + full pelvic lymph-node dissection']}], 'interventions': [{'name': 'identification of sentinel nodes + full pelvic lymph-node dissection', 'type': 'PROCEDURE', 'description': 'identification of sentinel nodes + full pelvic lymph-node dissection', 'armGroupLabels': ['Strategy B']}, {'name': 'only identification of sentinel nodes (without pelvic lymph-node dissection)', 'type': 'PROCEDURE', 'description': 'only identification of sentinel nodes (without pelvic lymph-node dissection)', 'armGroupLabels': ['Strategy A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Service de Gynécologie, Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}