Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354738
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-21
Brief Title:
Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment
Sponsor:
University Hospital Gasthuisberg
Organization:
University Hospital Gasthuisberg
Study Overview
Official Title:
Improving Endometrial Cancer Assessment by Combining the New techniqUe of GENomic Profiling With Surgical Extra uterIne disEase Assessment
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUGENIE
Brief 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None