Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365905
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-10
Brief Title:
Non-Invasive Identification of Endometrial CancerEndometrial Atypical Hyperplasia with an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Non-Invasive Identification of Endometrial CancerEndometrial Atypical Hyperplasia with an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions
Detailed Description:
PRIMARY OBJECTIVE
I Prospective validation of an artificial intelligence AI algorithm applied to transvaginal ultrasound TVUS to identify patients with premalignantmalignant in a population of women with postmenopausal bleeding PMB
OUTLINE This is an observational study
Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study
I Prospective validation of an artificial intelligence AI algorithm applied to transvaginal ultrasound TVUS to identify patients with premalignantmalignant in a population of women with postmenopausal bleeding PMB
OUTLINE This is an observational study
Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02550 | REGISTRY | None | None |
| 23-011680 | OTHER | Mayo Clinic in Rochester | None |