Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04473833
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2020-07-13
Brief Title:
Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
Sponsor:
John R van Nagell
Organization:
University of Kentucky
Study Overview
Official Title:
Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2023-11
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 is a large prospective single-arm cohort study of transvaginal ultrasonographic screening for ovarian cancer in intermediate to high-risk women from Kentucky Detection of ovarian malignancy often occurs subsequent to the initial transvaginal sonography TVS screen therefore it is important to offer continued screening to study participants based on our published algorithm Screening will be available to participants for as long as they elect to receive it The primary study endpoints are to determine if prospective serial transvaginal ultrasonography can decrease the false-positive FP percentage and improve the positive predictive value PPV as suggested by retrospective analysis without compromising the detection of true positives or promote the occurrence of false negatives
Detailed Description:
Women from every Kentucky county participate in the Kentucky Ovarian Cancer Screening Program Screening sites include Maysville Prestonsburg Greenup Elizabethtown Somerset Paducah and Lexington Offsite participants account for 14 of the screening population with 86 being screened in Lexington The long-term survival 20 year of women with screen-detected ovarian cancers is twice that of unscreened women 65 vs 32 Separation of cases into Type 1 and Type 2 ovarian cancer shows that screening improves the survival of both Type 1 and Type 2 ovarian cancers Type 1 ovarian carcinomas for the screened and unscreened populations were defined based on these WHO criteria mucinous carcinomas all grade clear cell carcinomas all grades endometrioid carcinomas grades 1 2 serous carcinomas grades 1 2 and malignant Brenners tumors all grades Type 2 ovarian carcinomas for the screened and unscreened populations were defined based on these criteria undifferentiated carcinomas endometrioid carcinomas grade 3 serous carcinomas grade 3 and carcinosarcomas
While long-term 20-year survival of women with Type 1 ovarian cancers detected by screening was significantly better than for unscreened women 81 v 46 respectively the survival benefit was even more pronounced for Type 2 ovarian cancers detected by screening of Kentucky women compared to unscreened Kentucky women 557 vs 03 respectively or unscreened women at UK Hospital 12 Screen-detected cases of Type 2 invasive ovarian cancers had better survival than unscreened cases when those detected had early- or late-stage disease However better survival was achieved when Type 2 ovarian cancers were detected at an early 72 compared to late-stage 46 Our data support the effectiveness of the screening protocol at the University of Kentucky and subsequent treatment in accordance with National Comprehensive Cancer Network guidelines
The significance of these findings is that our approach has resulted in the detection of both early-stage Type 1 and Type 2 ovarian cancers and these cases have had improved survival when compared to that of unscreened cases indicating that the screen-detected cases are associated with a potential survival advantage even for aggressive ovarian carcinomas
The primary objective of this study is to prospectively evaluate the false positive FP percentage generated by the ovarian screening algorithm and determine whether serial transvaginal ultrasonography can lower the FP percentage as demonstrated in the retrospective analysis The aim of serial ultrasonography is to decrease FP percentage to 032 positive predictive value of 24 without adversely impacting the results for true positives and false negatives on a per woman screened basis since this corresponds to a minimally acceptable positive predictive value of 24 or higher This assumes an average of three screening years for each new woman entering the program
While long-term 20-year survival of women with Type 1 ovarian cancers detected by screening was significantly better than for unscreened women 81 v 46 respectively the survival benefit was even more pronounced for Type 2 ovarian cancers detected by screening of Kentucky women compared to unscreened Kentucky women 557 vs 03 respectively or unscreened women at UK Hospital 12 Screen-detected cases of Type 2 invasive ovarian cancers had better survival than unscreened cases when those detected had early- or late-stage disease However better survival was achieved when Type 2 ovarian cancers were detected at an early 72 compared to late-stage 46 Our data support the effectiveness of the screening protocol at the University of Kentucky and subsequent treatment in accordance with National Comprehensive Cancer Network guidelines
The significance of these findings is that our approach has resulted in the detection of both early-stage Type 1 and Type 2 ovarian cancers and these cases have had improved survival when compared to that of unscreened cases indicating that the screen-detected cases are associated with a potential survival advantage even for aggressive ovarian carcinomas
The primary objective of this study is to prospectively evaluate the false positive FP percentage generated by the ovarian screening algorithm and determine whether serial transvaginal ultrasonography can lower the FP percentage as demonstrated in the retrospective analysis The aim of serial ultrasonography is to decrease FP percentage to 032 positive predictive value of 24 without adversely impacting the results for true positives and false negatives on a per woman screened basis since this corresponds to a minimally acceptable positive predictive value of 24 or higher This assumes an average of three screening years for each new woman entering the program
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