Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment

Trial Title: Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment

NCT ID: NCT06354738

Condition: Endometrial Cancer

Conditions: Official terms:
Endometrial Neoplasms

Conditions: Keywords:
Endometrial Cancer
Genomic profiling
Molecular classification
Disease staging

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging
Description: Surgical treatment will consist of total hysterectomy with bilateral salpingo-oophorectomy according to international guidelines. In low- and intermediate-risk EC patients, staging will include a sentinel lymph node (SLN) procedure. In high intermediate-risk and high-risk EC patients, lymph node staging will involve SLN procedure and/or pelvic and para-aortic lymph node dissection (LND), depending on the local protocol. The Study-related procedures include infracolic omentectomy or two separate omental representative biopsies, biopsies of all suspicious lesions as well as six peritoneal sites (bladder, pouch of Douglas, bilateral paracolic gutter and bilateral diaphragm). Stage IV patients will be treated according to European guidelines. When feasible, full surgical intervention (i.e. debulking) is recommended. If this cannot be achieved, a radiologic and/or histologic confirmation of tumor spread beyond the uterus will be accepted.
Arm group label: All women older than 18 newly diagnosed with endometrial cancer of all stages and histotypes

Summary: EUGENIE is a prospective multicentre interventional study, focused on improving endometrial cancer (EC) assessment by combining the new technique of genomic profiling with surgical extra uterine disease assessment. The investigators aim to correlate EC stage to each of the molecular subgroups of disease and thereby guide surgical treatment and staging of EC by determining the association between molecular classification and disease stage and evaluating if and how disease stage in each of the molecular subgroups associates with prognosis.

Detailed description: Current treatment for endometrial cancer (EC) includes a hysterectomy with bilateral salpingo-oophorectomy. Further surgical staging procedures (lymphadenectomy, peritoneum, and/or omentum biopsies) can be performed in order to detect metastases and determine the disease stage. The type and extent of this surgical staging depend on a pre-operative risk assessment and guides adjuvant treatment (chemo- or radiotherapy). However, this pre-operative risk assessment based on histology and imaging is relatively inaccurate: first, preoperative histology presents high intersubjective variability leading to poor reproducibility in the assignment of histotype and the concordance between preoperative histology and final histology is poor. In addition, preoperative imaging modalities are expensive, time-consuming, hampered by non-perfect accuracies, require specialized expertise, or present limitations in reproducibility and availability. As a result, this leads to an incorrect risk estimation of metastases at diagnosis in EC patients with a consequent over- or undertreatment of patients. Thus, there is an urgent need to develop risk stratification strategies that will better predict the presence and localization of metastases in EC patients and therefore more efficiently tailor surgical staging procedures. In 2013 The Cancer Genome Atlas (TCGA) Research Network developed a new molecularly driven classification system, that divides EC tumours into the well-known four molecular subgroups (POLE, MMRd, p53abn, NSMP) and has shown to surpass histologic subtyping and grading to more efficiently predict prognosis. However, the relation between the four molecular subgroups and the risk of tumour spread beyond the uterus at diagnosis has insufficiently been investigated so far and, as a consequence, surgical staging should not yet be adapted based on the molecular endometrial cancer subtype. Thus, new studies are needed to assess the value of surgical staging in this molecular era and EUGENIE Study has been developed to bridge this knowledge gap. The investigators believe that the future is in integrating morphologic and molecular findings, so the preoperative diagnosis will also support accurate surgical decision making and therefore a more tailored management of all EC patients.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Voluntary written informed consent of the participant or their legally authorized representative has been obtained before any screening procedures - Women ≥ 18 years - First diagnosis of EC, all disease stages and all histo-types Exclusion Criteria: - Participant has a history of pelvic or para-aortic lymph node dissection or sampling, previous pelvic (and/or para-aortic) radiotherapy, previous neoadjuvant chemotherapy - Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol - Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Study

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UZ Gasthuisberg, Katholieke Universiteit Leuven

Address:
City: Leuven
Zip: 3000
Country: Belgium

Status: Recruiting

Contact:
Last name: Ayaka Wakatsuki

Phone: +32 16 34 41 69
Email: ayaka.wakatsuki@uzleuven.be

Investigator:
Last name: Frédéric Amant, MD, PhD
Email: Principal Investigator

Start date: January 16, 2023

Completion date: November 1, 2028

Lead sponsor:
Agency: University Hospital, Gasthuisberg
Agency class: Other

Collaborator:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Collaborator:
Agency: University Medical Centre Maribor
Agency class: Other

Source: University Hospital, Gasthuisberg

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06354738
https://pubmed.ncbi.nlm.nih.gov/36977506/