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
- Diseases
- Cervical cancer
- 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
Sites (106)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Barretos Cancer Hospital Coordinator of this site? Confirm its status | Campo Grande | Brazil | Unknown status |
| Hospital Erasto Gaertner Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Brazilian National Cancer Institute Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| AC Camargo Cancer Center - Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Israelita Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Amaral Carvalho de Jaù Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CHUM - Centre Hospitalier de l'Universite de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CHU Québec (Hôtel Dieu) Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Allan Blair Cancer Centre (CASA) Coordinator of this site? Confirm its status | Regina | Canada | Unknown status |
| Saskatoon Cancer Centre.(CASS) Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| CIUSS de l'Estrie - Centre hospitalier universitaire de Sherbrooke - CAGH Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Clinical Research Unit at Vancouver Coastal Health Authority (CAVG) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| CHUV Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Cancer Hospital of University of Chinese Academy of Science Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The 1st Affiliated Hospital Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava-Poruba | Czechia | Unknown status |
| General University Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| University Hospital Bulovka Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Vivantes Humboldt-Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitätsklinikum Carl Gustav Carus Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Florence Nightingale Krankenhaus Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitätsklinikum Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Kliniken Essen-Mitte - Evang. Huyssens-Stiftung Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Frauenklinik Fürth Coordinator of this site? Confirm its status | Fürth | Germany | Unknown status |
| Universitätsklinikum Gießen und Marburg - UKGM Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Universitätsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Städtisches Klinikum Karlsruhe Coordinator of this site? Confirm its status | Karlsruhe | Germany | Unknown status |
| Klinikum Kassel Coordinator of this site? Confirm its status | Kassel | Germany | Unknown status |
| Universitatsklinikum Schleswig-Holstein - Campus Lubeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Klinikum der Universität München Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| UFK am Klinikum Südstradt Rostock Coordinator of this site? Confirm its status | Rostock | Germany | Unknown status |
| Universitaätsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Universitätsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Klinikum Wolfsburg Coordinator of this site? Confirm its status | Wolfsburg | Germany | Unknown status |
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital General Universitario de Castellón Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
| Hospital Universitario de Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Hospital Universitario de Girona Dr. Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hopital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clínico Universitario San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| CHU D'amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Clinique Tivoli-Ducos Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Center de Lutte Contre le Cancer François Baclesse Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU de CAEN Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Hopital Antoine Beclere Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
| CHU de Clermont-Ferrand - Hôpital d'Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre de lutte contre le cancer Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHI de Créteil Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU de Dijon - Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHRU de Lille - Hôpital Jeanne de Flandre Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Groupement Hospitalier Est - Hôpital Femme Mère Enfant Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital de la Conception Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut de Cancérologie de Montpellier Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CH de Mulhouse - Hôpital du Hasenrain Coordinator of this site? Confirm its status | Mulhouse | France | Unknown status |
| Institut de cancérologie de l'Ouest Centre René GAUDUCHEAU Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre de Lutte Contre le Cancer Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Grand Hôpital de l'Est Francilien Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Institut Curie - Site de Paris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Lariboisière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Groupe Hospitalier La Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Groupe Hospitalier Diaconesses Croix Saint-Simon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Bichat - Claude Bernard Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CH Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Hôpital de Poissy-Saint-Germain-en-Laye Coordinator of this site? Confirm its status | Poissy | France | Unknown status |
| CHU de Poitiers - Hôpital de la Milétrie Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| CHU de Reims Hôpital Robert Debré Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| Centre Jean Godinot Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU de Rennes- Hôpital Sud Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Clinique Mathilde Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHU de la Réunion Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Institut universitaire du cancer de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Centre de Lutte Contre le Cancer Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Basavatarakam Indo American Cancer Hospital & Research Institute Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Chittaranjan National Cancer Institute (CNCI) Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Istituto Europe di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale San Gerardo Monza Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Oslo Universitetssykehus HF, Radiumhospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| National Oncology Institute Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| University Hospital Trencin Coordinator of this site? Confirm its status | Trenčín | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.