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BIOMarkers in Endometrial Cancer - A phase III open label randomized trial to determine the efficacy of biomarker staging as compared to conventional staging in women with presumed early-stage endometrial cancer.
EU CTIS ID: 2023-505991-31-00
What this study is testing
To investigate the non-inferiority of biomarker staging to select women with presumed early-stage endometrial cancer to adjuvant treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed primary carcinoma in the endometrium
- Women able to understand and comply with planned study procedures
- Women with presumed FIGO stage I-II
- Planned surgery with curative intent
- Patient must be suitable candidates for surgery
- Patient must be suitable candidates for adjuvant treatment
You likely can't join if
- FIGO stage > II pre- or peroperatively
- FIGO stage IIIA or IIIB or IV at final pathology
- Women with a history of pelvic or abdominal radiotherapy
- Women who are pregnant
- Women in whom surgery with palliative intent only is planned
- Women with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity
See the full eligibility criteria
- Histologically confirmed primary carcinoma in the endometrium
- Women able to understand and comply with planned study procedures
- Women with presumed FIGO stage I-II
- Planned surgery with curative intent
- Patient must be suitable candidates for surgery
- Patient must be suitable candidates for adjuvant treatment
- ECOG performance status 0-2
- Patients who have signed an approved Informed Consent
- Age ≥ 18 years
- Subject has adequate organ function, defined as follows: Haemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Creatinine ≤1.5 × ULN AST and ALT ≤2.5 x ULN
- FIGO stage > II pre- or peroperatively
- FIGO stage IIIA or IIIB or IV at final pathology
- Women with a history of pelvic or abdominal radiotherapy
- Women who are pregnant
- Women in whom surgery with palliative intent only is planned
- Women with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity
- Women with iodine allergy cannot participate in the sentinel node part of the trial
- Women in whom macroscopic dissemination is suspected at preoperative imaging
- Women in whom macroscopic dissemination is confirmed during surgery
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.