Improving assessment of endometrial cancer using genomic profiling and surgical methods
Improving Endometrial Cancer Assessment by Combining the New techniqUe of GENomic Profiling With Surgical Extra uterIne disEase Assessment
This study is testing if combining genetic testing with surgery can help doctors better understand and treat endometrial cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Gasthuisberg Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06354738 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the assessment of endometrial cancer by integrating genomic profiling with surgical evaluation of extra uterine disease. It is a multicenter interventional study that seeks to correlate the stage of endometrial cancer with its molecular subgroups, thereby guiding surgical treatment and staging. The researchers will evaluate the association between molecular classification and disease stage, as well as its impact on prognosis. This approach addresses the limitations of current pre-operative risk assessments, which often lead to inaccurate staging and treatment decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are newly diagnosed with endometrial cancer, regardless of disease stage or histotype.
Not a fit: Patients with a history of pelvic or para-aortic lymph node dissection, previous pelvic radiotherapy, or those undergoing neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate staging and tailored treatment for patients with endometrial cancer, improving outcomes.
How similar studies have performed: Other studies have shown promise in using genomic profiling for cancer assessment, suggesting that this approach may lead to significant advancements in treatment strategies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven
- UZ Gasthuisberg, Katholieke Universiteit Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Frédéric Amant, MD, PhD — UZ Leuven Gasthuisberg
- Study coordinator: Frédéric Amant, MD, PhD
- Email: frederic.amant@uzleuven.be
- Phone: +3216342194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.