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  • Improving Endometrial cancer assessment by combining the new techniqUe of GENomic profiling with surgical Extra uterIne disEase assessment (EUGENIE)

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Clinical trial
Improving Endometrial cancer assessment by combining the new techniqUe of GENomic profiling with surgical Extra uterIne disEase assessment (EUGENIE)
  1. Jenneke C Kasius1,
  2. Rita Trozzi2,3,
  3. Johanna Pijnenborg4,
  4. Thaïs Baert5,
  5. Annouschka Laenen6,
  6. Anne-Sophie Van Rompuy7,8,
  7. Ignacio Zapardiel9,
  8. Giuseppe Vizzielli10,11,
  9. Jure Knez12,
  10. Francesco Fanfani2,3 and
  11. Frédéric Amant5,13
  1. 1 Department of Gynecological Oncology, Amsterdam University Medical Centres, Centre for Gynecological Oncology Amsterdam (CGOA), 22660 1100 DD, Amsterdam, The Netherlands
  2. 2 Department of Women, Children and Public Health Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
  3. 3 Facoltà di Medicina e Chirurgia, Università Cattolica del Sacro Cuore, Rome, Italy
  4. 4 Department of Obstetrics & Gynecology, Radboudumc, Nijmegen, The Netherlands
  5. 5 Division of Gynecologic Oncology; Department of Obstetrics and gynecology, KU Leuven University Hospitals Leuven, Leuven, Flanders, Belgium
  6. 6 Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), Katholieke Universiteit Leuven, Leuven, Flanders, Belgium
  7. 7 Department of Pathology, Katholieke Universiteit Leuven UZ Leuven, Leuven, Flanders, Belgium
  8. 8 Laboratory of Translational Cell & Tissue Research, Department of Imaging and Pathology, Katholieke Universiteit Leuven, Leuven, Flanders, Belgium
  9. 9 Gynecologic Oncology, La Paz University Hospital, Madrid, University, Spain
  10. 10 Department of Medical Area (DAME), University of Udine, Udine, Friuli-Venezia Giulia, Italy
  11. 11 Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda sanitaria universitaria Friuli Centrale, Udine, Friuli-Venezia Giulia, Italy
  12. 12 Department for Gynaecological Oncology, University Medical Centre Maribor, Maribor, Slovenia
  13. 13 Center for Gynaecologic Oncology, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands
  1. Correspondence to Professor Frédéric Amant, Division of Gynecologic Oncology; Department of Obstetrics and gynecology, KU Leuven University Hospitals Leuven, Leuven, Flanders, Belgium; frederic.amant{at}uzleuven.be

Abstract

Background The molecular classification of endometrial cancer revolutionized our knowledge of its biology but so far has not affected our surgical approach. The exact risk of extra-uterine metastasis and hence the type of surgical staging for each of the four molecular subgroups are currently unknown.

Primary Objective To determine the association between molecular classification and disease stage.

Study Hypothesis Each endometrial cancer molecular subgroup has a specific pattern of spread and this pattern of spread could guide the extent of surgical staging.

Trial Design Prospective, multicenter study

Major Inclusion/Exclusion Criteria Participants eligible for inclusion in this study must meet all the following criteria: women ≥18 years with primary endometrial cancer, any histology and stage.

Primary Endpoint Number and site of metastasis in each endometrial cancer molecular subgroup.

Sample Size 1000 patients will be enrolled.

Estimated Dates for Completing Accrual and Presenting Results The trial will last 6 years: 4 years of accrual, and 2 years of follow-up of all patients. Results on staging and oncological outcomes are expected in 2027 and 2029, respectively.

Trial Registration The study has been accepted by UZ Leuven Ethical Committee. Belg. Reg. nr: B3222022000997

  • Endometrial Neoplasms
  • Gynecologic Surgical Procedures

Data availability statement

Data are available upon request.

http://dx.doi.org/10.1136/ijgc-2023-004289

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    Data availability statement

    Data are available upon request.

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    Footnotes

    • Twitter @Ritarella_

    • JCK and RT contributed equally.

    • Contributors JCK and RT contributed equally to this paper. JCK, JP, FA: conceptualization; JCK, RT, FA: protocol development and manuscript writing; AL: statistical analysis; JP, TB, A-SVR, IZ, GV, JK, FF: critical analysis, final editing; FA: guarantor.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; internally peer reviewed.