Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2025-12-17 @ 3:09 AM
Study NCT ID:
NCT04867109
Status:
None
Last Update Posted:
2021-09-17 00:00:00
First Post:
2021-04-13 00:00:00
Brief Title:
HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
Status:
None
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
METRODEC
Brief Summary:
Endometrial cancer is the most common pelvic gynecological cancer in France, ranking 5th among cancers in women in terms of incidence.
The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies.
The diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention. The latter is mostly reassuring.
These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery.
At present, there is no biological marker used in current practice. In the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis, the pathology results are often reassuring. These procedures could have been avoided, especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky. The appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.
The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies.
The diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention. The latter is mostly reassuring.
These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery.
At present, there is no biological marker used in current practice. In the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis, the pathology results are often reassuring. These procedures could have been avoided, especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky. The appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.
Detailed Description:
Endometrial cancer is the most common pelvic gynecological cancer in France ranking 5th among cancers in women in terms of incidence
The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies
The diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention The latter is mostly reassuring
These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery
At present there is no biological marker used in current practice In the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis the pathology results are often reassuring These procedures could have been avoided especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky The appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries
This study aims to explore the sensitivity of an innovative marker HE4 in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings
The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies
The diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention The latter is mostly reassuring
These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery
At present there is no biological marker used in current practice In the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis the pathology results are often reassuring These procedures could have been avoided especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky The appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries
This study aims to explore the sensitivity of an innovative marker HE4 in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings
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