Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294886
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-28
Brief Title:
Vaginal Fluid Collection for Detection of Endometrial Cancer
Sponsor:
Innovis LLC
Organization:
Innovis LLC
Study Overview
Official Title:
Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer EC endometrial hyperplasia AEH with atypia or endometrial intraepithelial neoplasia EIN
The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC AEH and EIN
The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC AEH and EIN
Detailed Description:
For participants providing written informed consent to participate in the study samples of vaginal fluid will be obtained by the Principal Investigator PI during a pelvic examination All vaginal fluid samples will be collected 7 days after the endometrial biopsy and prior to initiating any therapeutic interventions including surgery chemotherapy radiation or hormonal therapy PIs will be provided with multiple individually packaged Copan eNat sterile sample collection kits including a swab and a transport tube containing a stabilizer and preservative medium as well as a pre-addressed shipping container and single-use tubes of sterile saline solution After vaginal fluid sample collection the swab will be inserted into the tube for storage and subsequent shipping to the Sponsors designated laboratory The samples can be stored at ambient temperature and should be shipped to the designated laboratory within 24 hours of collection Sites will provide the Sponsor with de-identified endometrial biopsy histopathology report and post-surgery histopathology report if any confirming the histopathological diagnosis of EC AEH or EIN The final diagnosis will be based on the most severe clinical histopathology at diagnostic endometrial sampling or surgery
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