An interventional study of total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging in Endometrial Cancer, sponsored by University Hospital, Gasthuisberg. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by University Hospital, Gasthuisberg · Not applicable, Interventional, and Treatment
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Among 76 studies in Endometrial Neoplasms with a site in Belgium — 23 open to participants now, 34 under way, 12 of them phase 3. Endometrial Neoplasms · Belgium.
Among the 76 studies in Endometrial Neoplasms with a site in Belgium, this one is the 2nd largest by planned enrollment of the 69 interventional ones that give a count, is one of 7 that started in 2023, is one of 3 with no phase, reaches primary completion later than 23 of the 33 other live ones, and was the 64th registered.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 472 are open to participants now.
Browse Endometrial Neoplasms studies →23 of the 76 studies in Endometrial Neoplasms with a site in Belgium are open now. Recruiting first, the newest first:
Universiteit Antwerpen · Sites in Belgium
Ages 18+ · Women only
Boehringer Ingelheim · Sites in Belgium, United States, France and 3 more countries
Ages 18+
Eikon Therapeutics · Sites in Belgium, United States, Australia and 12 more countries
Ages 18+
Genmab · Sites in Belgium, United States, Australia and 16 more countries
Ages 18+ · Women only
AstraZeneca · Sites in Belgium, United States, Argentina and 25 more countries
Ages 18+ · Women only
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 358 Endometrial Neoplasms studies recruiting now, 268 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
76 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 37 · Phase 3 20
First in 1988; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Median enrollment 256 across the 69 interventional studies, 170 across the 6 observational. Of the 36 that completed or were terminated, 15 (42%) have results posted.
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51 of 76 have an industry lead sponsor. The 10 most frequent:
University Hospital, Gasthuisberg is the lead sponsor of 51 studies on the registry; 4 are open to participants now.
University Hospital, Gasthuisberg has 2 studies filed under Endometrial Neoplasms — fewer than ten, so there is no comparison to draw.
8 of the studies in Endometrial Neoplasms with a site in Belgium that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04634877Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) | 2026-11-20 |
| NCT05173987Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) | 2027-05-27 |
| NCT07044336Phase 3AstraZenecaPuxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | 2027-10-15 |
| NCT05527184AbbVieFirst in Human Study of IMGN151 in Recurrent Gynaecological Cancers | 2027-02 |
| NCT05856981Sairopa B.V.Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors | 2027-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 76 studies in Endometrial Neoplasms with a site in Belgium, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients must undergo total hysterectomy and bilateral salpingo-oophorectomy or bilateral salpingectomy if premenopausal status and the lymph-node assessment according to European guidelines and local protocol. A comprehensive surgical peritoneal staging is required, which includes omentectomy/omental biopsies and six peritoneal biopsies.
Procedure: total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging
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.
Endometrial cancer stage
Endometrial cancer stage assessed according to the 2009 an 2023 International Federation of Gynecology and Obstetrics (FIGO) staging
Time frame: 72 months
Molecular type of endometrial cancer
Tumor classification using the molecular classification as proposed by either ProMisE or TRANSPORTEC. Groups will be classified as follows: 1. MMR: Mismatch Repair Protein Status will be determined as a surrogate for microsatellite instability (MSI) by considering the immunohistochemical (IHC) staining of the MMR proteins. In case of loss of staining of one or more MMR proteins, the EC will be classified as MMR deficient (MMRd), otherwise, the carcinoma will be coded as MMR proficient (MMRp). 2. POLE: if the POLE exonuclease domain mutations (EDM) gene is mutated (i.e. a pathogenic mutation), the tumour will be classified as POLE. 3. p53 IHC: TP53 mutation status will be determined via IHC and in case of inconclusive p53 staining, also sequencing. 4. NSMP: a carcinoma that has not been stratified into groups 1), 2) or 3) will be categorized into the NSMP (no specific molecular profile or copy number low).
Time frame: 72 months
Overall survival
Overall survival
Time frame: 72 months
Time to recurrence
Time to recurrence
Time frame: 72 months
Plan to share: Yes
Started Jan 2023 (actual). Primary completion is estimated for Nov 2028, 69 months after the start.
Of 195 non-industry interventional studies with no phase under Endometrial Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 69 months is above that.
Counting every sponsor, half of 201 studies reached it within 43 months; a quarter within 19 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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University Hospital, Gasthuisberg