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NCT03386734Active, not recruiting

International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

Source: ClinicalTrials.gov · Last updated 8 Jul 2024

Brief summary (registry, in English)

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). There 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".

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
989 (actual)
First submitted
15 Dec 2017
Start date
3 May 2018
Primary completion date
May 2027
Lead sponsor
Centre Hospitalier Universitaire de Besancon
NCT number
NCT03386734

What you commit to

  • Study type: Interventional
  • Participants enrolled: 989
  • From 3 May 2018 to the primary completion date, May 2027
  • 106 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • E 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

Who the study is looking for

  • I 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (106)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHC MontLégia
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LiègeBelgiumUnknown status
Barretos Cancer Hospital
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Campo GrandeBrazilUnknown status
Hospital Erasto Gaertner
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CuritibaBrazilUnknown status
Brazilian National Cancer Institute
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Rio de JaneiroBrazilUnknown status
AC Camargo Cancer Center - Sao Paulo
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São PauloBrazilUnknown status
Hospital Israelita Albert Einstein
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São PauloBrazilUnknown status
Hospital Amaral Carvalho de Jaù
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São PauloBrazilUnknown status
CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)
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MontrealCanadaUnknown status
CHUM - Centre Hospitalier de l'Universite de Montreal
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MontrealCanadaUnknown status
CHU Québec (Hôtel Dieu)
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QuébecCanadaUnknown status
Allan Blair Cancer Centre (CASA)
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ReginaCanadaUnknown status
Saskatoon Cancer Centre.(CASS)
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SaskatoonCanadaUnknown status
CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH
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SherbrookeCanadaUnknown status
Clinical Research Unit at Vancouver Coastal Health Authority (CAVG)
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VancouverCanadaUnknown status
CancerCare Manitoba
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WinnipegCanadaUnknown status
CHUV
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LausanneSwitzerlandUnknown status
Cancer Hospital of University of Chinese Academy of Science
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HangzhouChinaUnknown status
The 1st Affiliated Hospital
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WenzhouChinaUnknown status
University Hospital Olomouc
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OlomoucCzechiaUnknown status
University Hospital Ostrava
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Ostrava-PorubaCzechiaUnknown status
General University Hospital
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PragueCzechiaUnknown status
University Hospital Bulovka
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PragueCzechiaUnknown status
Vivantes Humboldt-Klinikum
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BerlinGermanyUnknown status
Universitätsklinikum Carl Gustav Carus
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DresdenGermanyUnknown status
Florence Nightingale Krankenhaus
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DüsseldorfGermanyUnknown status
Universitätsklinikum Düsseldorf
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DüsseldorfGermanyUnknown status
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
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EssenGermanyUnknown status
Frauenklinik Fürth
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FürthGermanyUnknown status
Universitätsklinikum Gießen und Marburg - UKGM Giessen
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GiessenGermanyUnknown status
Universitätsklinikum Hamburg-Eppendorf
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HamburgGermanyUnknown status
Medizinische Hochschule Hannover
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HanoverGermanyUnknown status
Universitätsklinikum Jena
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JenaGermanyUnknown status
Städtisches Klinikum Karlsruhe
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KarlsruheGermanyUnknown status
Klinikum Kassel
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KasselGermanyUnknown status
Universitatsklinikum Schleswig-Holstein - Campus Lubeck
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LübeckGermanyUnknown status
Klinikum der Universität München
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MünchenGermanyUnknown status
Universitätsklinikum Münster
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MünsterGermanyUnknown status
UFK am Klinikum Südstradt Rostock
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RostockGermanyUnknown status
Universitaätsklinikum Tübingen
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TübingenGermanyUnknown status
Universitätsklinikum Ulm
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UlmGermanyUnknown status
Klinikum Wolfsburg
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WolfsburgGermanyUnknown status
Hospital Universitario Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital General Universitario de Castellón
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CastellonSpainUnknown status
Hospital Universitario de Donostia
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Donostia / San SebastianSpainUnknown status
Hospital Universitario de Girona Dr. Josep Trueta
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GironaSpainUnknown status
Hopital Clinico Universitario de Valencia
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GironaSpainUnknown status
Hospital Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Clínico Universitario San Carlos
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MadridSpainUnknown status
Hospital Alvaro Cunqueiro
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VigoSpainUnknown status
CHU D'amiens
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AmiensFranceUnknown status
CHU de Besançon
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BesançonFranceUnknown status
Clinique Tivoli-Ducos
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BordeauxFranceUnknown status
Institut Bergonie
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BordeauxFranceUnknown status
Center de Lutte Contre le Cancer François Baclesse
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CaenFranceUnknown status
CHU de CAEN
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CaenFranceUnknown status
Hopital Antoine Beclere
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ClamartFranceUnknown status
CHU de Clermont-Ferrand - Hôpital d'Estaing
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Clermont-FerrandFranceUnknown status
Centre de lutte contre le cancer Jean Perrin
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Clermont-FerrandFranceUnknown status
CHI de Créteil
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CréteilFranceUnknown status
Centre Georges François Leclerc
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DijonFranceUnknown status
CHU de Dijon - Bourgogne
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DijonFranceUnknown status
Hopital Bicetre
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Le Kremlin-BicêtreFranceUnknown status
Centre Oscar Lambret
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LilleFranceUnknown status
CHRU de Lille - Hôpital Jeanne de Flandre
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LilleFranceUnknown status
CHU de Limoges
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LimogesFranceUnknown status
Groupement Hospitalier Est - Hôpital Femme Mère Enfant
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LyonFranceUnknown status
Hôpital de la Conception
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MarseilleFranceUnknown status
Institut Paoli-Calmettes
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MarseilleFranceUnknown status
Hôpital Saint Joseph
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MarseilleFranceUnknown status
Institut de Cancérologie de Montpellier Val d'Aurelle
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MontpellierFranceUnknown status
CH de Mulhouse - Hôpital du Hasenrain
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MulhouseFranceUnknown status
Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU
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NantesFranceUnknown status
Centre de Lutte Contre le Cancer Antoine Lacassagne
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NiceFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
Hôpital Tenon
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ParisFranceUnknown status
Grand Hôpital de l'Est Francilien
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ParisFranceUnknown status
Institut Curie - Site de Paris
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ParisFranceUnknown status
Hôpital Lariboisière
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ParisFranceUnknown status
Groupe Hospitalier La Pitié Salpêtrière
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ParisFranceUnknown status
Groupe Hospitalier Diaconesses Croix Saint-Simon
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ParisFranceUnknown status
Centre Hospitalier Bichat - Claude Bernard
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ParisFranceUnknown status
CH Lyon Sud
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Pierre-BéniteFranceUnknown status
Hôpital de Poissy-Saint-Germain-en-Laye
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PoissyFranceUnknown status
CHU de Poitiers - Hôpital de la Milétrie
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PoitiersFranceUnknown status
CHU de Reims Hôpital Robert Debré
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ReimsFranceUnknown status
Centre Jean Godinot
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ReimsFranceUnknown status
CHU de Rennes- Hôpital Sud
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RennesFranceUnknown status
Centre Henri Becquerel
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RouenFranceUnknown status
Clinique Mathilde
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RouenFranceUnknown status
CHU de la Réunion
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Saint-DenisFranceUnknown status
Hopitaux Universitaires de Strasbourg
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StrasbourgFranceUnknown status
Institut universitaire du cancer de Toulouse
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ToulouseFranceUnknown status
Institut de Cancérologie de Lorraine
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Vandœuvre-lès-NancyFranceUnknown status
Centre de Lutte Contre le Cancer Gustave Roussy
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VillejuifFranceUnknown status
Basavatarakam Indo American Cancer Hospital & Research Institute
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HyderabadIndiaUnknown status
Chittaranjan National Cancer Institute (CNCI)
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KolkataIndiaUnknown status
Istituto Europe di Oncologia
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MilanItalyUnknown status
Ospedale San Gerardo Monza
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MonzaItalyUnknown status
Saitama Medical University International Medical Center
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SaitamaJapanUnknown status
Oslo Universitetssykehus HF, Radiumhospitalet
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OsloNorwayUnknown status
National Oncology Institute
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BratislavaSlovakiaUnknown status
University Hospital Bratislava
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BratislavaSlovakiaUnknown status
University Hospital Trencin
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TrenčínSlovakiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.